Aortic Valve Stenosis With InsufficiencyTRITONNCT01445171

Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve

A study testing Aortic Valve Replacement with EDWARDS INTUITY Valve System in people with Aortic Valve Stenosis With Insufficiency and Aortic Valve Stenosis, run by Edwards Lifesciences at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this clinical investigation is to confirm that the safety and performance of the EDWARDS INTUITY Valve System. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Aortic Valve Stenosis With Insufficiency, Aortic Valve Stenosis
What is being tested?: Aortic Valve Replacement with EDWARDS INTUITY Valve System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 295 participants
Where: 6 sitesin 2 countries
Study dates: Jan 2010to Dec 2017
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

18 years or older
Aortic stenosis or stenosis-insufficiency of aortic valve requiring a planned replacement as indicated in the preoperative evaluation;
Scheduled to undergo planned aortic valve replacement with or without concomitant coronary bypass surgery, MAZE procedure, septal myectomy, pacemaker/ICD implant and or atrial appendage occlusion/removal.
Signed and dated the informed consent form prior to investigation procedures;
Geographically stable and agrees to attend Follow up assessments at the hospital of surgical services for a maximum of 5 years.

Who cannot join

Pure aortic insufficiency
Requires emergency surgery
Aneurysm of the aortic root and/or ascending aorta requiring surgical intervention
Left ventricular ejection fraction of ≤ 25%
Active endocarditis within 3 months prior to the scheduled aortic valve replacement surgery
Concomitant valve (mitral, tricuspid, or pulmonic) disease requiring repair with an annuloplasty ring or replacement with prosthesis

Show all 19Show fewer

Prior mitral, tricuspid or pulmonic valve surgery, which included implantation of a bioprosthetic valve, mechanical valve, or annuloplasty ring.
Myocardial infarction (MI) within 1 month prior to the scheduled aortic valve replacement surgery
Previously implanted with EDWARDS INTUITY Aortic valve; alcohol or drug abuser
Disease limiting life expectancy to less than 12 months
Pregnant or lactating
Currently participating in another drug or device clinical investigation;
Documented blood diatheses
Requires non-cardiac procedures such as carotid procedures or mediastinal tumor removal
Had a stroke or transient ischemic attack (TIA) within 6-months prior to scheduled aortic valve replacement surgery
Study site pre-operative echocardiographic assessment shows evidence of an intracardiac mass, thrombus, or vegetation
Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days of procedure
Documented renal insufficiency as determined by Serum creatinine ≥ 200 µmol/L (2.27 mg/dL) at screening or end-stage renal disease requiring chronic dialysis
Documented hyperparathyroidism

Trial locations and contacts

6 sites in 2 countries.

Country

City, postcode or hospital

6 sites in 2 countries

Germany5 sites

Kerchoff Klinik-Bad Nauheim
Bad Nauheim, 61231
Herzzentrum Uniklink Koln-Klinik und Poliklinik fur Herz und Thoraxzchirurgie
Cologne, 50937
MHH-Medizinische Hoschschule Hannover
Hanover, 30625
University Leipzig: Herzzentrum Leipzig Gmbh
Leipzig, 04289
Klinikum der Universitat Muchen-Grosshadern; Clinic at the University of Munich
Munich, 81377

Other trials in Germany

Austria1 site

AKH Vienna-Allgemeines Krankenhaus der Stadt Wien; University Vienna
Vienna, 1090

Other trials in Austria

About this study

The purpose of this clinical investigation is to confirm that the safety and performance of the EDWARDS INTUITY Valve System.

Read the detailed description

This is a two-phase, non-randomized, prospective, single arm, multi-center clinical investigation. Each subject in Phase 1 and Phase 2 is consented for a period of 5 years. All subjects will be assessed for clinical follow-up at the following intervals: Discharge, 1 month, 3 months, 1 year and annually thereafter until 5 years of follow-up is achieved per subject.

Conditions: Aortic Valve Stenosis With Insufficiency, Aortic Valve Stenosis
Being tested: Aortic Valve Replacement with EDWARDS INTUITY Valve System
Keywords: Aortic Valve Replacement
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.

Aortic Valve Replacement with EDWARDS INTUITY Valve SystemDevice
Aortic Valve bioprosthesis

Study groups in NCT01445171
Study group	Role	What they receive
Study Valve	Other	Subjects act as own control Receives: Device: Aortic Valve Replacement with EDWARDS INTUITY Valve System

What is being measured

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

Percent of Early Adverse Events
Number of early adverse events occurring within 30 days of procedure divided by the total number of enrolled subjects times 100.
Measured: Events occuring within 30 days of procedure
Percent of Late Adverse Events
Number of late adverse events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).
Measured: Events occurring >= 31 days and up through 5 years post-implant

Timeline

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

Jan 2010Dec 2017

First posted3 Oct 2011 (estimated)
Study startJan 2010
Primary completionDec 2017
Study completionDec 2017

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 (5)Papers the sponsor has linked to this study.
Other trials for Aortic Valve Stenosis With InsufficiencyStudies of the same condition, open and under way.
More trials run by Edwards LifesciencesThe sponsor's other registered studies.
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: 295 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01445171
Sponsor's protocol ID: 2009-01
Acronym: TRITON
Status last verified: Aug 2023
First submitted: 5 Aug 2011
Last updated: 1 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Laufer G, Haverich A, Andreas M, Mohr FW, Walther T, Shrestha M, Rahmanian P, Holzhey D, Roth M, Schmitz C, Schramm R, Giot C, Wahlers TCW. Long-term outcomes of a rapid deployment aortic valve: data up to 5 years. Eur J Cardiothorac Surg. 2017 Aug 1;52(2):281-287. doi: 10.1093/ejcts/ezx103.
PubMed 28453629
Haverich A, Wahlers TC, Borger MA, Shrestha M, Kocher AA, Walther T, Roth M, Misfeld M, Mohr FW, Kempfert J, Dohmen PM, Schmitz C, Rahmanian P, Wiedemann D, Duhay FG, Laufer G. Three-year hemodynamic performance, left ventricular mass regression, and prosthetic-patient mismatch after rapid deployment aortic valve replacement in 287 patients. J Thorac Cardiovasc Surg. 2014 Dec;148(6):2854-60. doi: 10.1016/j.jtcvs.2014.07.049. Epub 2014 Aug 1.
PubMed 25218544
Kocher AA, Laufer G, Haverich A, Shrestha M, Walther T, Misfeld M, Kempfert J, Gillam L, Schmitz C, Wahlers TC, Wippermann J, Mohr FW, Roth M, Skwara A, Rahmanian P, Wiedemann D, Borger MA. One-year outcomes of the Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve (TRITON) trial: a prospective multicenter study of rapid-deployment aortic valve replacement with the EDWARDS INTUITY Valve System. J Thorac Cardiovasc Surg. 2013 Jan;145(1):110-5; discussion 115-6. doi: 10.1016/j.jtcvs.2012.07.108. Epub 2012 Oct 8.
PubMed 23058665
Wahlers TCW, Andreas M, Rahmanian P, Candolfi P, Zemanova B, Giot C, Ferrari E, Laufer G. Outcomes of a Rapid Deployment Aortic Valve Versus Its Conventional Counterpart: A Propensity-Matched Analysis. Innovations (Phila). 2018 May/Jun;13(3):177-183. doi: 10.1097/IMI.0000000000000509.
PubMed 29912142
Alaklabi AM, Abdul Rab S, Sabbah BN, Maklad AE, Dokollari A, Van den Eynde J, Pompeu Sa M, Arjomandi Rad A, Ahsan MR, Fatehi Hassanabad A. Innovations in Aortic Valve Replacement: A Comprehensive Overview of the Intuity Rapid Deployment Valve. Cardiol Rev. 2026 Jan-Feb 01;34(1):30-39. doi: 10.1097/CRD.0000000000000657. Epub 2024 Feb 9.
PubMed 38334371

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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Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
Aortic Stenosis, Mitral Regurgitation
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
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Recruiting
Assessment of Coronary Artery Disease Before Transcatheter Aortic Valve Replacement: A Randomized, Multicenter, Non-Inferiority Trial
Aortic Valve Stenosis and Insufficiency, Coronary Artery Disease(CAD)
Recruiting
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit
Active, not recruiting
Transcatheter Aortic Valve Replacement Versu Surgical Aortix Valve Replacement for Treating Elderly Patients With Severe Aortic Stenosis and Small Aortic Annuli: A Prospective Randomized Study The VIVA Trial
Degenerative Aortic Valve Disease, Aortic Stenosis

All Aortic Valve Stenosis With Insufficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve
ClinicalTrials.gov ID: NCT01445171
Acronym / sponsor ID: TRITON / 2009-01
Conditions: Aortic Valve Stenosis With Insufficiency, Aortic Valve Stenosis
Keywords: Aortic Valve Replacement
Study type: Interventional
Recruitment status: Completed
Enrolment: 295 participants (actual)
Lead sponsor: Edwards LifesciencesIndustry (pharma, biotech, devices)
Study start: Jan 2010
Primary completion: Dec 2017 (actual)
Study completion: Dec 2017 (actual)
First posted: 3 Oct 2011 (estimated)
Results: Posted 17 Feb 2020

Clinical summary

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

The purpose of this clinical investigation is to confirm that the safety and performance of the EDWARDS INTUITY Valve System.

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
Study Valve	Other	Device: Aortic Valve Replacement with EDWARDS INTUITY Valve SystemSubjects act as own control

Who may qualify

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

Key inclusion criteria (5 listed)

18 years or older
Aortic stenosis or stenosis-insufficiency of aortic valve requiring a planned replacement as indicated in the preoperative evaluation;
Scheduled to undergo planned aortic valve replacement with or without concomitant coronary bypass surgery, MAZE procedure, septal myectomy, pacemaker/ICD implant and or atrial appendage occlusion/removal.
Signed and dated the informed consent form prior to investigation procedures;
Geographically stable and agrees to attend Follow up assessments at the hospital of surgical services for a maximum of 5 years.

Key exclusion criteria (19 listed)

Pure aortic insufficiency
Requires emergency surgery
Aneurysm of the aortic root and/or ascending aorta requiring surgical intervention
Left ventricular ejection fraction of ≤ 25%
Active endocarditis within 3 months prior to the scheduled aortic valve replacement surgery

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
Aortic Valve Replacement with EDWARDS INTUITY Valve SystemAortic Valve bioprosthesis	Device	Study Valve

Primary outcome

Percent of Early Adverse Events
Time frame: Events occuring within 30 days of procedure
Number of early adverse events occurring within 30 days of procedure divided by the total number of enrolled subjects times 100.
Percent of Late Adverse Events
Time frame: Events occurring >= 31 days and up through 5 years post-implant
Number of late adverse events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).

Results and safety

Results posted to the registry on 17 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
INTUITY Aortic Valve and INTUITY Delivery System	295	200

Primary outcome: Percent of Early Adverse Events

Time frame: Events occuring within 30 days of procedure. Number. Unit: Percentage of subjects

Measure	INTUITY Aortic Valve and INTUITY Delivery System n = 287
All Cause Mortality	1.7
Trial Valve Related Mortality	1.0
Thromboembolism	4.5
Valve Thrombosis	0.0
Major Bleeding	7.3
All Paravalvular Leak (OPC)	1.0
Hemolysis	0.7
Endocarditis	0.0

Population analysed: The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.

Primary outcome: Percent of Late Adverse Events

Time frame: Events occurring >= 31 days and up through 5 years post-implant. Number. Unit: Percentage of late adverse events

Measure	INTUITY Aortic Valve and INTUITY Delivery System n = 287
All Cause Mortality	3.8
Trial Valve Related Mortality	0.4
Thromboembolism	1.9
Valve Thrombosis	0.0
Major Bleeding	2.1
All Paravalvular Leak (OPC)	0.6
Hemolysis	0.2
Endocarditis	0.3

Population analysed: The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.

Adverse events

Time frame: Events occurring from baseline through five years post-implant. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
INTUITY Aortic Valve and INTUITY Delivery System	233 of 287 (81.2%)	189 of 287 (65.9%)	51 of 287

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 28453629Laufer G, Haverich A, Andreas M, Mohr FW, Walther T, Shrestha M, Rahmanian P, Holzhey D, Roth M, Schmitz C, Schramm R, Giot C, Wahlers TCW. Long-term outcomes of a rapid deployment aortic valve: data up to 5 years. Eur J Cardiothorac Surg. 2017 Aug 1;52(2):281-287. doi: 10.1093/ejcts/ezx103.
Results publication: PubMed 25218544Haverich A, Wahlers TC, Borger MA, Shrestha M, Kocher AA, Walther T, Roth M, Misfeld M, Mohr FW, Kempfert J, Dohmen PM, Schmitz C, Rahmanian P, Wiedemann D, Duhay FG, Laufer G. Three-year hemodynamic performance, left ventricular mass regression, and prosthetic-patient mismatch after rapid deployment aortic valve replacement in 287 patients. J Thorac Cardiovasc Surg. 2014 Dec;148(6):2854-60. doi: 10.1016/j.jtcvs.2014.07.049. Epub 2014 Aug 1.
Results publication: PubMed 23058665Kocher AA, Laufer G, Haverich A, Shrestha M, Walther T, Misfeld M, Kempfert J, Gillam L, Schmitz C, Wahlers TC, Wippermann J, Mohr FW, Roth M, Skwara A, Rahmanian P, Wiedemann D, Borger MA. One-year outcomes of the Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve (TRITON) trial: a prospective multicenter study of rapid-deployment aortic valve replacement with the EDWARDS INTUITY Valve System. J Thorac Cardiovasc Surg. 2013 Jan;145(1):110-5; discussion 115-6. doi: 10.1016/j.jtcvs.2012.07.108. Epub 2012 Oct 8.
Results publication: PubMed 29912142Wahlers TCW, Andreas M, Rahmanian P, Candolfi P, Zemanova B, Giot C, Ferrari E, Laufer G. Outcomes of a Rapid Deployment Aortic Valve Versus Its Conventional Counterpart: A Propensity-Matched Analysis. Innovations (Phila). 2018 May/Jun;13(3):177-183. doi: 10.1097/IMI.0000000000000509.
Derived from this study: PubMed 38334371Alaklabi AM, Abdul Rab S, Sabbah BN, Maklad AE, Dokollari A, Van den Eynde J, Pompeu Sa M, Arjomandi Rad A, Ahsan MR, Fatehi Hassanabad A. Innovations in Aortic Valve Replacement: A Comprehensive Overview of the Intuity Rapid Deployment Valve. Cardiol Rev. 2026 Jan-Feb 01;34(1):30-39. doi: 10.1097/CRD.0000000000000657. Epub 2024 Feb 9.
New York Heart Association ClassificationLink provided by the sponsor.

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Not yet recruitingObservational study
Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
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RecruitingObservational study
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Active, not recruiting
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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.

Prof Axel Haverich study director

MHH Hannover

6 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 19 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: finished, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany, Austria. 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 17 Feb 2020). 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?

Percent of Early Adverse Events (time frame: Events occuring within 30 days of procedure). The study lists 2 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 NCT01445171, which also lists 5 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 1 Sep 2023.