Aortic StenosisPERIGONNCT02088554

PERIGON Pivotal Trial

A study testing Model 400 aortic valve bioprosthesis in people with Aortic Stenosis, run by Medtronic Cardiac Surgery at 38 sites in 8 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Aortic Stenosis
What is being tested?: Model 400 aortic valve bioprosthesis
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,312 participants
Where: 38 sitesin 8 countries
Study dates: 12 May 2014to 31 Dec 2035
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient has moderate or greater aortic stenosis or regurgitation, and there is clinical indication for replacement of their native or prosthetic aortic valve with a bioprosthesis, with or without concomitant procedures, which are limited to any of the following:
Left atrial appendage (LAA) ligation ii. CABG (coronary artery bypass grafting) iii. Patent foramen ovale (PFO) closure iv. Ascending aortic aneurysm or dissection repair not requiring circulatory arrest v. Resection of a sub-aortic membrane not requiring myectomy
Patient is geographically stable and willing to return to the implanting site for all follow-up visits
Patient is of legal age to provide informed consent in the country where they enroll in the trial
Patient has been adequately informed of risks and requirements of the trial and is willing and able to provide informed consent for participation in the clinical trial

Who cannot join

Patient has a pre-existing prosthetic valve or annuloplasty device in another position or requires replacement or repair of the mitral, pulmonary or tricuspid valve
Patient has had previous implant and then explant of the Model 400 aortic valve bioprosthesis
Patient presents with active endocarditis, active myocarditis or other systemic infection
Patient has an anatomical abnormality which would increase surgical risk of morbidity or mortality, including:
Ascending aortic aneurysm or dissection repair requiring circulatory arrest
Acute Type A aortic dissection

Show all 26Show fewer

Ventricular aneurysm
Porcelain aorta
Hostile mediastinum
Hypertrophic obstructive cardiomyopathy (HOCM)
Documented pulmonary hypertension (systolic >60mmHg)
Patient has a non-cardiac major or progressive disease, with a life expectancy of less than 2 years. These conditions include, but are not limited to:
Child-Pugh Class C liver disease
Terminal cancer
End-stage lung disease
Patient has renal failure, defined as dialysis therapy or glomerular filtration rate(GFR)<30 mL/min/1.73 m2
Patient has hyperparathyroidism
Patient is participating in another investigational device or drug trial or observational competitive study
Patient is pregnant, lactating or planning to become pregnant during the trial period
Patient has a documented history of substance (drug or alcohol) abuse
Patient has greater than mild mitral valve regurgitation or greater than mild tricuspid valve regurgitation as assessed by echocardiography
Patient has systolic ejection fraction (EF)<20% as assessed by echocardiography
Patient has Grade IV Diastolic Dysfunction
Patient has documented bleeding diatheses
Patient has had an acute preoperative neurological deficit or myocardial infarction and has not returned to baseline or stabilized ≥30 days prior to enrollment
Patient requires emergency surgery

Trial locations and contacts

38 sites in 8 countries.

Country

City, postcode or hospital

38 sites in 8 countries

United States20 sites

University of Michigan Cardiovascular Center
Ann Arbor, Michigan, 48109-5853
Piedmont Hospital
Atlanta, Georgia, 30309
University of Colorado Hospital
Aurora, Colorado, 80045-2545
Cardiothoracic and Vascular Surgeons (CTVS)
Austin, Texas, 78756-4080
University of Maryland Medical Center
Baltimore, Maryland, 21201
Massachusetts General Hospital
Boston, Massachusetts, 02114
Maimonides Medical Center
Brooklyn, New York, 11219
Cleveland Clinic
Cleveland, Ohio, 44195-0001
Riverside Methodist Hospital (OhioHealth)
Columbus, Ohio, 43214
University of Florida Shands
Gainesville, Florida, 32610
Hartford Hospital
Hartford, Connecticut, 06102
Houston Methodist Hospital
Houston, Texas, 77030
University of Southern California (USC) University Hospital
Los Angeles, California, 90033-5313
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215-4330
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407-1139
The Mount Sinai Medical Center
New York, New York, 10029
New York-Presbyterian Hospital/Columbia University Medical Center
New York, New York, 10032
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73135
University of Washington Medical Center
Seattle, Washington, 98195-0001
ProMedica Toledo Hospital
Toledo, Ohio, 43606

Other trials in United States

Canada5 sites

London Health Sciences Centre - University Campus
London, Ontario, N6A 5A5
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
Québec, G1V 4G5
Toronto General Hospital
Toronto, M5G 2C4

Other trials in Canada

Germany5 sites

Uniklinik Köln
Cologne, Köln, 50924
Universitäts Klinikum Frankfurt - Goethe-Universität
Frankfurt, 60590
Medizinische Hochschule Hannover
Hanover, 30625
Herzzentrum Leipzig GmbH
Leipzig, 04289
Deutsches Herzzentrum München
Munich, München, DE 80636

Other trials in Germany

France2 sites

Hôpital Cardiologique du Haut-Lévêque
Bordeaux, 33604
Hôpital Bichat - Claude Bernard
Paris, 75018

Other trials in France

Netherlands2 sites

Leids Universitair Medisch Centrum (LUMC)
Leiden, 2333 ZA
Erasmus MC
Rotterdam, 3015 CE

Other trials in Netherlands

Switzerland2 sites

Inselspital - Universitätsspital Bern
Bern, 3010
UniversitätsSpital Zürich
Zurich, 8091

Other trials in Switzerland

Italy1 site

Ospedale San Raffaele - Milano
Milan, 20132

Other trials in Italy

United Kingdom1 site

Guy's & St Thomas' NHS Foundation Trust - St Thomas' Hospital
London, SE1 7EH

Other trials in United Kingdom

About this study

Official title: Medtronic PERIcardial SurGical AOrtic Valve ReplacemeNt Pivotal Trial A Multi-center, Non-randomized Trial to Determine the Safety and Effectiveness of the Model 400 Aortic Valve Bioprosthesis in Patients With Aortic Valve Disease

To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.

Read the detailed description

This is a prospective, interventional, non-randomized, worldwide, multi-center trial. A maximum of 1300 subjects were to be implanted at a maximum of 40 sites in the US, Europe and Canada. The trial includes male and female patients of legal age to provide informed consent in the country where they enrolled in the trial, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic valve. Subjects are followed out to 5 years, and select sites follow subjects out to 12 years. Enrollment closed on 14Jul2017 for all valve sizes. Enrollment was reopened in Apr2019 for the 29mm valve size at a subset of US and Canadian sites to obtain greater patient numbers required by the FDA to support US commercial approval of this valve size. Enrollment for the 29mm valve size closed on 14Feb2023.

Conditions: Aortic Stenosis
Being tested: Model 400 aortic valve bioprosthesis
Medical subject headings: Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Model 400 aortic valve bioprosthesisDevice

Study groups in NCT02088554
Study group	Role	What they receive
Model 400 aortic valve bioprosthesis	Experimental	Not described Receives: Device: Model 400 aortic valve bioprosthesis

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant
Safety of the valve is evaluated by the time-related incidence of valve-related adverse events and death. The following valve-related adverse events are evaluated in this study: Thromboembolism, Thrombosis, Hemorrhage, Paravalvular leak (PVL), Endocarditis, Hemolysis, Structural valve deterioration, Non-structural dysfunction, Reintervention, Explant, and Death. A minimum of 15 participants per valve size are evaluated. The incidence rates will be used to summarize valve-related adverse events and death.
Measured: 1 year post-implant
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year
At each timepoint, a minimum of 15 participants per valve size evaluated for change in New York Heart Association (NYHA) functional classification from baseline to 1 year post-procedure.
Measure Description: Cardiac Disease with Functional Classes (lower value is more desirable than higher value) I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath.
II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain.
III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain.
IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort.
Measured: Discharge (up to 30 days), 3-6 months, and 1 year post-implant
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure
A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The effective orifice area (EOA) is measured as the minimal cross-sectional area of the blood flow downstream of the aortic valve.
Measured: Discharge (up to 30 days), 3-6 months, 1 year post-implant
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant
A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory for effective orifice area index (EOAI = EOA/BSA) Effective orifice area index is equal to the effective orifice area (EOA) in cm^2 divided by body surface area (BSA) in m^2.
The achievement criterion for the effective orifice area index (EOAI) is defined to be ≥0.6 cm^2/m^2 12 months after the procedure. This criterion is in accordance with the definition of severe aortic stenosis in the American College of Cardiology (ACC) / American Heart Association (AHA) guidelines for the management of valvular heart disease.
Measured: Discharge (up to 30 days), 3-6 months, and 1 year post-implant
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year
A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory.
The peak pressure gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury.
Measured: Measured at discharge (up to 30 days), 3-6 months, and 1 year post-implant
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant
A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The mean pressure gradient is the average flow of blood through the aortic valve measured in millimeters of mercury.
Measured: Discharge (up to 30 days), 3-6 months, and 1 year post-implant
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant
A minimum of 15 participants per valve size will have performance index (L/Min) measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The performance index is the measurement of the effective orifice area divided by the native orifice area.
Measured: Discharge (up to 30 days), 3-6 months, and 1 year post-implant
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant
Cardiac output is the amount of blood pumped by the heart per minute. A minimum of 15 participants per valve size were evaluated for this outcome measure by transthoracic echocardiography technique and assessed by an independent core laboratory.
Measured: Discharge (up to 30 days), 3-6 months, and 1 year post-implant
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant
A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory.
The cardiac index is an assessment of the cardiac output based on a patient's size measured by dividing the cardiac output by the patient's body's surface area.
Measured: Discharge (up to 30 days), 3-6 months, and 1 year post-implant

Secondary outcomes (9)

Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death Annually Through 5 Years Post-implant
Safety of the valve is evaluated by the time-related incidence of valve-related adverse events and death. The following valve-related adverse events are evaluated in this study: Thromboembolism, Thrombosis, Hemorrhage, Paravalvular leak (PVL), Endocarditis, Hemolysis, Structural valve deterioration, Non-structural dysfunction, Reintervention, Explant, and Death. The Kaplan-Meier event rates will be used to summarize valve-related adverse events and death. The Kaplan-Meier rate and the corresponding 95% confidence interval will be presented for each visit interval.
Measured: Annually, at years 2, 3, 4, and 5 post-implant
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 5 Years Post-implant
At each timepoint, participants were evaluated for change in New York Heart Association (NYHA) functional classification from baseline through 5 years post-procedure.
Measure Description: Cardiac Disease with Functional Classes (lower value is more desirable than higher value) I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath.
II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain.
III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain.
IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort.
Measured: Annually, at years 2, 3, 4, and 5 post-implant
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 5 Years Post-procedure
Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The effective orifice area (EOA) is measured as the minimal cross-sectional area of the blood flow downstream of the aortic valve.
Measured: Annually, at years 2, 3, 4, and 5 post-implant
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 5 Years Post-implant
Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory for effective orifice area index (EOAI = EOA/BSA) Effective orifice area index is equal to the effective orifice area (EOA) in cm^2 divided by body surface area (BSA) in m^2.
The achievement criterion for the effective orifice area index (EOAI) is defined to be ≥0.6 cm^2/m^2 12 months after the procedure. This criterion is in accordance with the definition of severe aortic stenosis in the American College of Cardiology (ACC) / American Heart Association (AHA) guidelines for the management of valvular heart disease.
Measured: Annually, at years 2, 3, 4, and 5 post-implant
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 5 Years Post-implant
Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory.
The peak pressure gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury.
Measured: Annually, at years 2, 3, 4, and 5 post-implant
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 5 Years Post-implant
Evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The mean pressure gradient is the average flow of blood through the aortic valve measured in millimeters of mercury.
Measured: Annually, at years 2, 3, 4, and 5 post-implant
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 5 Years Post-implant
Performance index (L/Min) measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The performance index is the measurement of the effective orifice area divided by the native orifice area.
Measured: Annually, at years 2, 3, 4, and 5 post-implant
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 5 Years Post-implant
Cardiac output is the amount of blood pumped by the heart per minute, evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory.
Measured: Annually, at years 2, 3, 4, and 5 post-implant
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 5 Years Post-implant
Evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory.
The cardiac index is an assessment of the cardiac output based on a patient's size measured by dividing the cardiac output by the patient's body's surface area.
Measured: Annually, at years 2, 3, 4, and 5 post-implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 May 201431 Dec 2035

First posted17 Mar 2014 (estimated)
Study start12 May 2014
Primary completion17 Apr 2023
Study completion31 Dec 2035 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Aortic StenosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1,312 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02088554
Sponsor's protocol ID: PERIGON
Acronym: PERIGON
Status last verified: Apr 2026
First submitted: 4 Mar 2014
Last updated: 29 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Velders BJJ, Vriesendorp MD, Weissman NJ, Sabik JF 3rd, Reardon MJ, Dagenais F, Moront MG, Rao V, Fukuhara S, Gunzinger R, van Leeuwen WJ, Brown WM, Groenwold RHH, Klautz RJM, Asch FM. Core Laboratory Versus Center-Reported Echocardiographic Assessment of the Native and Bioprosthetic Aortic Valve. Echocardiography. 2024 Dec;41(12):e70047. doi: 10.1111/echo.70047.
PubMed 39624936
Klautz RJM, Rao V, Reardon MJ, Deeb GM, Dagenais F, Moront MG, Little SH, Labrousse L, Patel HJ, Ito S, Li S, Sabik JF 3rd, Oh JK. Examining the typical hemodynamic performance of nearly 3000 modern surgical aortic bioprostheses. Eur J Cardiothorac Surg. 2024 May 3;65(5):ezae122. doi: 10.1093/ejcts/ezae122.
PubMed 38710669
Velders BJJ, Vriesendorp MD, De Lind Van Wijngaarden RAF, Rao V, Reardon MJ, Shrestha M, Chu MWA, Sabik JF 3rd, Liu F, Klautz RJM. Perioperative care differences of surgical aortic valve replacement between North America and Europe. Heart. 2023 Jun 26;109(14):1106-1112. doi: 10.1136/heartjnl-2023-322350.
PubMed 36963820
Klautz RJM, Kappetein AP, Lange R, Dagenais F, Labrousse L, Bapat V, Moront M, Misfeld M, Zeng C, Sabik Iii JF; PERIGON Investigators. Safety, effectiveness and haemodynamic performance of a new stented aortic valve bioprosthesis. Eur J Cardiothorac Surg. 2017 Sep 1;52(3):425-431. doi: 10.1093/ejcts/ezx066.
PubMed 28475690

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Aortic Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Medtronic PERIcardial SurGical AOrtic Valve ReplacemeNt Pivotal Trial A Multi-center, Non-randomized Trial to Determine the Safety and Effectiveness of the Model 400 Aortic Valve Bioprosthesis in Patients With Aortic Valve Disease
ClinicalTrials.gov ID: NCT02088554
Acronym / sponsor ID: PERIGON / PERIGON
Conditions: Aortic Stenosis
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 1,312 participants (actual)
Lead sponsor: Medtronic Cardiac SurgeryIndustry (pharma, biotech, devices)
Collaborators: Medtronic
Study start: 12 May 2014 (actual)
Primary completion: 17 Apr 2023 (actual)
Study completion: 31 Dec 2035 (estimated)
First posted: 17 Mar 2014 (estimated)
Results: Posted 4 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Model 400 aortic valve bioprosthesis	Experimental	Device: Model 400 aortic valve bioprosthesis

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patient has moderate or greater aortic stenosis or regurgitation, and there is clinical indication for replacement of their native or prosthetic aortic valve with a bioprosthesis, with or without concomitant procedures, which are limited to any of the following:
Patient is geographically stable and willing to return to the implanting site for all follow-up visits
Patient is of legal age to provide informed consent in the country where they enroll in the trial
Patient has been adequately informed of risks and requirements of the trial and is willing and able to provide informed consent for participation in the clinical trial

Key exclusion criteria (26 listed)

Patient has a pre-existing prosthetic valve or annuloplasty device in another position or requires replacement or repair of the mitral, pulmonary or tricuspid valve
Patient has had previous implant and then explant of the Model 400 aortic valve bioprosthesis
Patient presents with active endocarditis, active myocarditis or other systemic infection
Patient has an anatomical abnormality which would increase surgical risk of morbidity or mortality, including:
Patient has a non-cardiac major or progressive disease, with a life expectancy of less than 2 years. These conditions include, but are not limited to:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Model 400 aortic valve bioprosthesis	Device	Model 400 aortic valve bioprosthesis

Primary outcome

Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant
Time frame: 1 year post-implant
Safety of the valve is evaluated by the time-related incidence of valve-related adverse events and death. The following valve-related adverse events are evaluated in this study: Thromboembolism, Thrombosis, Hemorrhage, Paravalvular leak (PVL), Endocarditis, Hemolysis, Structural valve deterioration, Non-structural dysfunction, Reintervention, Explant, and Death. A minimum of 15 participants per valve size are evaluated. The incidence rates will be used to summarize valve-related adverse events and death.
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year
Time frame: Discharge (up to 30 days), 3-6 months, and 1 year post-implant
At each timepoint, a minimum of 15 participants per valve size evaluated for change in New York Heart Association (NYHA) functional classification from baseline to 1 year post-procedure. Measure Description: Cardiac Disease with Functional Classes (lower value is more desirable than higher value) I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort.
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure
Time frame: Discharge (up to 30 days), 3-6 months, 1 year post-implant
A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The effective orifice area (EOA) is measured as the minimal cross-sectional area of the blood flow downstream of the aortic valve.
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant
Time frame: Discharge (up to 30 days), 3-6 months, and 1 year post-implant
A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory for effective orifice area index (EOAI = EOA/BSA) Effective orifice area index is equal to the effective orifice area (EOA) in cm^2 divided by body surface area (BSA) in m^2. The achievement criterion for the effective orifice area index (EOAI) is defined to be ≥0.6 cm^2/m^2 12 months after the procedure. This criterion is in accordance with the definition of severe aortic stenosis in the American College of Cardiology (ACC) / American Heart Association (AHA) guidelines for the management of valvular heart disease.
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year
Time frame: Measured at discharge (up to 30 days), 3-6 months, and 1 year post-implant
A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The peak pressure gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury.
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant
Time frame: Discharge (up to 30 days), 3-6 months, and 1 year post-implant
A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The mean pressure gradient is the average flow of blood through the aortic valve measured in millimeters of mercury.
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant
Time frame: Discharge (up to 30 days), 3-6 months, and 1 year post-implant
A minimum of 15 participants per valve size will have performance index (L/Min) measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The performance index is the measurement of the effective orifice area divided by the native orifice area.
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant
Time frame: Discharge (up to 30 days), 3-6 months, and 1 year post-implant
Cardiac output is the amount of blood pumped by the heart per minute. A minimum of 15 participants per valve size were evaluated for this outcome measure by transthoracic echocardiography technique and assessed by an independent core laboratory.
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant
Time frame: Discharge (up to 30 days), 3-6 months, and 1 year post-implant
A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The cardiac index is an assessment of the cardiac output based on a patient's size measured by dividing the cardiac output by the patient's body's surface area.

9 secondary outcomes

Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death Annually Through 5 Years Post-implant
Time frame: Annually, at years 2, 3, 4, and 5 post-implant
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 5 Years Post-implant
Time frame: Annually, at years 2, 3, 4, and 5 post-implant
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 5 Years Post-procedure
Time frame: Annually, at years 2, 3, 4, and 5 post-implant
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 5 Years Post-implant
Time frame: Annually, at years 2, 3, 4, and 5 post-implant
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 5 Years Post-implant
Time frame: Annually, at years 2, 3, 4, and 5 post-implant
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 5 Years Post-implant
Time frame: Annually, at years 2, 3, 4, and 5 post-implant
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 5 Years Post-implant
Time frame: Annually, at years 2, 3, 4, and 5 post-implant
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 5 Years Post-implant
Time frame: Annually, at years 2, 3, 4, and 5 post-implant
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 5 Years Post-implant
Time frame: Annually, at years 2, 3, 4, and 5 post-implant

Results and safety

Results posted to the registry on 4 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Medtronic Model 400 Avalus Bioprosthetic Aortic Valve	1,312	268

Primary outcome: Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant

Time frame: 1 year post-implant. Number. Unit: percentage of participants with event

Measure	Medtronic Avalus Valve 19mm n = 42	Medtronic Avalus Valve 21mm n = 211	Medtronic Avalus Valve 23mm n = 401	Medtronic Avalus Valve 25mm n = 350	Medtronic Avalus Valve 27mm n = 101	Medtronic Avalus Valve 29mm n = 26	Medtronic Avalus Valve (17mm - 29mm) n = 1132
All death	9.5	2.8	2.2	2.9	4.0	3.8	3.0
Valve- related death	0.0	0.9	0.2	0.0	0.0	0.0	0.3
Thromboembolism	0.0	2.8	2.7	2.9	4.0	3.8	2.8
Valve thrombosis	0.0	0.0	0.0	0.0	0.0	0.0	0.0
All hemorrhage	7.1	3.8	6.7	4.3	7.9	0.0	5.4
Major hemorrhage	7.1	0.5	5.0	3.4	5.0	0.0	3.6
All paravalvular leak	0.0	0.5	0.5	0.6	1.0	0.0	0.5
Major paravalvular leak	0.0	0.5	0.0	0.3	0.0	0.0	0.2

Primary outcome: Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year

Time frame: Discharge (up to 30 days), 3-6 months, and 1 year post-implant. Count of participants. Unit: Participants

Measure	Medtronic Avalus Valve 19mm n = 42	Medtronic Avalus Valve 21mm n = 211	Medtronic Avalus Valve 23mm n = 401	Medtronic Avalus Valve 25mm n = 350	Medtronic Avalus Valve 27mm n = 101	Medtronic Avalus Valve 29mm n = 26	Medtronic Avalus Valve (17mm - 29mm) n = 1132
Discharge up to 30 days: Improved 3 Classes	0	0	5	2	2	0	9
Discharge up to 30 days: Improved 2 Classes	5	14	30	27	9	1	86
Discharge up to 30 days: Improved 1 Class	21	83	131	108	26	12	382
Discharge up to 30 days: No Change	12	61	118	116	23	7	337
Discharge up to 30 days: Worsened 1 Class	0	15	16	18	10	3	62
Discharge up to 30 days: Worsened 2 Classes	0	1	2	1	0	0	4
Discharge up to 30 days: Worsened 3 Classes	0	0	0	0	0	0	0
3-6 Months: Improved 3 Classes	0	1	4	6	1	0	12

Population analysed: Difference in the overall number of participants analyzed and of those analyzed at each timepoint is due to classification not assessed, classification was unable to be assessed, or the participant exited the trial before that timepoint. For 29mm participants, difference in total number of participants analyzed was also due to participants who have not yet reached specified timepoint.

Primary outcome: Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure

Time frame: Discharge (up to 30 days), 3-6 months, 1 year post-implant. Mean (Standard Deviation). Unit: cm^2

Measure	Medtronic Avalus Valve 19mm n = 42	Medtronic Avalus Valve 21mm n = 211	Medtronic Avalus Valve 23mm n = 401	Medtronic Avalus Valve 25mm n = 350	Medtronic Avalus Valve 27mm n = 101	Medtronic Avalus Valve 29mm n = 26	Medtronic Avalus Valve (17mm - 29mm) n = 1132
Discharge (up to 30 days)	1.23 (0.24)	1.35 (0.30)	1.59 (0.34)	1.68 (0.37)	1.88 (0.42)	2.29 (0.68)	1.60 (0.40)
3-6 Months	1.22 (0.27)	1.30 (0.26)	1.54 (0.30)	1.66 (0.32)	1.89 (0.42)	2.51 (0.71)	1.57 (0.39)
1 Year	1.09 (0.23)	1.26 (0.25)	1.48 (0.33)	1.60 (0.34)	1.76 (0.35)	2.42 (0.59)	1.50 (0.38)

Population analysed: At each timepoint, only subjects with echocardiography core lab data are included in the rows below.

Primary outcome: Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant

Time frame: Discharge (up to 30 days), 3-6 months, and 1 year post-implant. Mean (Standard Deviation). Unit: cm^2/m^2

Measure	Medtronic Avalus Valve 19mm n = 42	Medtronic Avalus Valve 21mm n = 211	Medtronic Avalus Valve 23mm n = 401	Medtronic Avalus Valve 25mm n = 350	Medtronic Avalus Valve 27mm n = 101	Medtronic Avalus Valve 29mm n = 26	Medtronic Avalus Valve (17mm - 29mm) n = 1132
Discharge (up to 30 days)	0.71 (0.16)	0.74 (0.18)	0.81 (0.20)	0.81 (0.19)	0.89 (0.23)	1.07 (0.3)	0.81 (0.20)
3-6 Months	0.71 (0.17)	0.72 (0.16)	0.79 (0.17)	0.81 (0.17)	0.90 (0.22)	1.16 (0.31)	0.80 (0.19)
1 Year	0.63 (0.14)	0.70 (0.15)	0.76 (0.18)	0.78 (0.17)	0.82 (0.17)	1.14 (0.28)	0.76 (0.18)

Population analysed: At each timepoint, only subjects with echocardiography core lab data are included in the rows below.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Site reported adverse events and serious adverse events data collected from implant through 1 year.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Medtronic Avalus Valve (All Valve Sizes)	638 of 1,132 (56.4%)	1,105 of 1,132 (97.6%)	170 of 1,132

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39624936Velders BJJ, Vriesendorp MD, Weissman NJ, Sabik JF 3rd, Reardon MJ, Dagenais F, Moront MG, Rao V, Fukuhara S, Gunzinger R, van Leeuwen WJ, Brown WM, Groenwold RHH, Klautz RJM, Asch FM. Core Laboratory Versus Center-Reported Echocardiographic Assessment of the Native and Bioprosthetic Aortic Valve. Echocardiography. 2024 Dec;41(12):e70047. doi: 10.1111/echo.70047.
Derived from this study: PubMed 38710669Klautz RJM, Rao V, Reardon MJ, Deeb GM, Dagenais F, Moront MG, Little SH, Labrousse L, Patel HJ, Ito S, Li S, Sabik JF 3rd, Oh JK. Examining the typical hemodynamic performance of nearly 3000 modern surgical aortic bioprostheses. Eur J Cardiothorac Surg. 2024 May 3;65(5):ezae122. doi: 10.1093/ejcts/ezae122.
Derived from this study: PubMed 36963820Velders BJJ, Vriesendorp MD, De Lind Van Wijngaarden RAF, Rao V, Reardon MJ, Shrestha M, Chu MWA, Sabik JF 3rd, Liu F, Klautz RJM. Perioperative care differences of surgical aortic valve replacement between North America and Europe. Heart. 2023 Jun 26;109(14):1106-1112. doi: 10.1136/heartjnl-2023-322350.
Derived from this study: PubMed 28475690Klautz RJM, Kappetein AP, Lange R, Dagenais F, Labrousse L, Bapat V, Moront M, Misfeld M, Zeng C, Sabik Iii JF; PERIGON Investigators. Safety, effectiveness and haemodynamic performance of a new stented aortic valve bioprosthesis. Eur J Cardiothorac Surg. 2017 Sep 1;52(3):425-431. doi: 10.1093/ejcts/ezx066.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joseph Sabik, MD principal investigator

University Hospital Cleveland Medical Center (Not a recruiting site)

Prof. Dr. Robert Johannes Menno Klautz, MD principal investigator

Leiden University Medical Center

38 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Model 400 aortic valve bioprosthesis in people with Aortic Stenosis, run by Medtronic Cardiac Surgery at 38 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Canada, Germany, France, Netherlands and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant (time frame: 1 year post-implant). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02088554, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.