Aortic Valve DisorderNCT01651052

Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000

A study testing Heart Valve Surgery in people with Aortic Valve Disorder and Aortic Valve Insufficiency, run by Edwards Lifesciences at 2 sites in Poland.

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 observational trial is to gather further clinical data to confirm the safety and performance of the Edwards Pericardial Aortic Bioprosthesis, Model 11000 in this trial population. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Aortic Valve Disorder, Aortic Valve Insufficiency, Aortic Valve Stenosis
What is being tested?: Heart Valve Surgery
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 133 participants
Where: 2 sitesPoland
Study dates: Jul 2011to Jul 2018
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
Require replacement of aortic valve
Signed informed consent
Willing to return to study site for follow-up visits

Who cannot join

Active endocarditis/myocarditis (< 3 months)
Myocardial infarction (< 30 days)
Renal insufficiency/ End-stage renal disease
Life expectancy (< 1 year)
Requires multiple valve replacement/repair
Requiring emergent aortic valve surgery
Pregnant or lactating

Trial locations and contacts

2 sites in 1 country.

Poland2 sites

Krakowski Szpital Specjalistyczny im. Jana Pawła II
Krakow, 31-202
Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego
Warsaw, 04-628

Other trials in Poland

About this study

The purpose of this observational trial is to gather further clinical data to confirm the safety and performance of the Edwards Pericardial Aortic Bioprosthesis, Model 11000 in this trial population.

Read the detailed description

This is a prospective, non-randomized, non-controlled observational clinical trial. Up to 200 subjects will be enrolled at up to 6 participating clinical sites. The trial will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic valve. Patients will be followed and assessed after implant for up to 5 years.

Conditions: Aortic Valve Disorder, Aortic Valve Insufficiency, Aortic Valve Stenosis, Heart Failure, Coronary Artery Disease
Being tested: Heart Valve Surgery
Keywords: Aortic valve replacement/regurgitation
Medical subject headings: Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Valve Stenosis, Heart Failure, Coronary Artery Disease, Gastroesophageal Reflux

What participants receive

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

Heart Valve SurgeryProcedure or surgery
Implant of an aortic valve, Model 11000

Study groups in NCT01651052
Study group	Role	What they receive
Aortic Bioprosthesis, Model 11000	Experimental	Aortic valve replacement therapy Receives: Procedure: Heart Valve Surgery

What is being measured

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

Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage)
Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100
Measured: Events occurring within 30 days of procedure
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)
Number of late events divided by the total number of late patient years x 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

Secondary outcomes (5)

Subject's Average Mean Gradient Measurements
Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.
Measured: Baseline through 5-Year (at each scheduled follow-up visit)
Subject's Average Effective Orifice Area Measurements
Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time.
Measured: Baseline through 5-Year (at each scheduled follow-up visit)
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline.
The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.
Class I. Patients with cardiac disease but without resulting limitation of physical activity.
Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.
Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.
Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.
Symptoms of heart failure or the anginal syndrome may be present even at rest.
Measured: 3-6 Months and 1 through 5 Years compared to baseline
Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey
The Medical Outcomes Study Short-Form 12 (SF-12) contains two components - the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
The SF-12 Physical Component Summary questionnaire scale ranges from a maximum of 100, which reflects the best health status to a minimum of 0, which reflects the worst health status.
The SF-12 Mental Component Summary scale ranges from a maximum of 100, which reflects the best health status to a minimum of 0, which reflects the worst health status.
Measured: Baseline and one year follow-up
Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time
The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.
Measured: Baseline and 1 Year

Timeline

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

Jul 2011Jul 2018

First posted26 Jul 2012 (estimated)
Study startJul 2011
Primary completionJul 2018
Study completionJul 2018

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 Valve DisorderStudies 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: 133 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01651052
Sponsor's protocol ID: 2010-03
Status last verified: Jul 2019
First submitted: 18 Jul 2012
Last updated: 26 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

De La Fuente AB, Wright GA, Olin JM, Duhay FG, Kapelak B, Bochenek M, Bartus K, Sadowski J. Advanced Integrity Preservation Technology Reduces Bioprosthesis Calcification While Preserving Performance and Safety. J Heart Valve Dis. 2015 Jan;24(1):101-9.
PubMed 26182627
Bartus K, Litwinowicz R, Kusmierczyk M, Bilewska A, Bochenek M, Stapor M, Wozniak S, Rozanski J, Sadowski J, Kapelak B. Primary safety and effectiveness feasibility study after surgical aortic valve replacement with a new generation bioprosthesis: one-year outcomes. Kardiol Pol. 2018;76(3):618-624. doi: 10.5603/KP.a2017.0262. Epub 2018 Jan 3.
PubMed 29297188
Sadowski J, Bartus K, Kapelak B, Chung A, Stapor M, Bochenek M. Aortic valve replacement with a novel anti-calcification technology platform. Kardiol Pol. 2015;73(5):317-22. doi: 10.5603/KP.a2014.0214. Epub 2014 Nov 5.
PubMed 25371311
Bartus K, Litwinowicz R, Bilewska A, Stapor M, Bochenek M, Rozanski J, Sadowski J, Filip G, Kusmierczyk M, Kapelak B. Final 5-year outcomes following aortic valve replacement with a RESILIA tissue bioprosthesis. Eur J Cardiothorac Surg. 2021 Jan 29;59(2):434-441. doi: 10.1093/ejcts/ezaa311.
PubMed 33141188

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

Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic

All Aortic Valve Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000
ClinicalTrials.gov ID: NCT01651052
Acronym / sponsor ID: 2010-03
Conditions: Aortic Valve Disorder, Aortic Valve Insufficiency, Aortic Valve Stenosis, Heart Failure, Coronary Artery Disease
Keywords: Aortic valve replacement/regurgitation
Study type: Interventional
Recruitment status: Completed
Enrolment: 133 participants (actual)
Lead sponsor: Edwards LifesciencesIndustry (pharma, biotech, devices)
Study start: Jul 2011
Primary completion: Jul 2018 (actual)
Study completion: Jul 2018 (actual)
First posted: 26 Jul 2012 (estimated)
Results: Posted 26 Jul 2019

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 observational trial is to gather further clinical data to confirm the safety and performance of the Edwards Pericardial Aortic Bioprosthesis, Model 11000 in this trial population.

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
Aortic Bioprosthesis, Model 11000	Experimental	Procedure: Heart Valve SurgeryAortic valve replacement therapy

Who may qualify

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

Key inclusion criteria (4 listed)

18 years or older
Require replacement of aortic valve
Signed informed consent
Willing to return to study site for follow-up visits

Key exclusion criteria (7 listed)

Active endocarditis/myocarditis (< 3 months)
Myocardial infarction (< 30 days)
Renal insufficiency/ End-stage renal disease
Life expectancy (< 1 year)
Requires multiple valve replacement/repair

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
Heart Valve SurgeryImplant of an aortic valve, Model 11000	Procedure or surgery	Aortic Bioprosthesis, Model 11000

Primary outcome

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

5 secondary outcomes

Subject's Average Mean Gradient Measurements
Time frame: Baseline through 5-Year (at each scheduled follow-up visit)
Subject's Average Effective Orifice Area Measurements
Time frame: Baseline through 5-Year (at each scheduled follow-up visit)
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline.
Time frame: 3-6 Months and 1 through 5 Years compared to baseline
Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey
Time frame: Baseline and one year follow-up
Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time
Time frame: Baseline and 1 Year

Results and safety

Results posted to the registry on 26 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aortic Bioprosthesis, Model 11000	133	107

Primary outcome: Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage)

Time frame: Events occurring within 30 days of procedure. Number. Unit: percentage

Measure	Aortic Bioprosthesis, Model 11000 n = 133
All Cause Mortality	2.3
Trial valve-related Mortality	0.8
Study Valve Related Reoperation	0.0
Explant	0.0
Thromboembolism	2.3
Valve Thrombosis	0.0
Bleeding Event	8.3
Major Bleeding Event	6.8

Primary outcome: Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)

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

Measure	Aortic Bioprosthesis, Model 11000 n = 133
All Cause Mortality	3.2
Trial valve-related mortality	0.7
Study Valve Related Reoperation	0.2
Explant	0.2
Thromboembolism	0.4
Valve Thrombosis	0.2
Bleeding Event	0.4
Major Bleeding Event	0.4

5 secondary outcomes are reported in the full results.

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
Aortic Bioprosthesis, Model 11000	74 of 133 (55.6%)	41 of 133 (30.8%)	21 of 133

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26182627De La Fuente AB, Wright GA, Olin JM, Duhay FG, Kapelak B, Bochenek M, Bartus K, Sadowski J. Advanced Integrity Preservation Technology Reduces Bioprosthesis Calcification While Preserving Performance and Safety. J Heart Valve Dis. 2015 Jan;24(1):101-9.
Results publication: PubMed 29297188Bartus K, Litwinowicz R, Kusmierczyk M, Bilewska A, Bochenek M, Stapor M, Wozniak S, Rozanski J, Sadowski J, Kapelak B. Primary safety and effectiveness feasibility study after surgical aortic valve replacement with a new generation bioprosthesis: one-year outcomes. Kardiol Pol. 2018;76(3):618-624. doi: 10.5603/KP.a2017.0262. Epub 2018 Jan 3.
Results publication: PubMed 25371311Sadowski J, Bartus K, Kapelak B, Chung A, Stapor M, Bochenek M. Aortic valve replacement with a novel anti-calcification technology platform. Kardiol Pol. 2015;73(5):317-22. doi: 10.5603/KP.a2014.0214. Epub 2014 Nov 5.
Derived from this study: PubMed 33141188Bartus K, Litwinowicz R, Bilewska A, Stapor M, Bochenek M, Rozanski J, Sadowski J, Filip G, Kusmierczyk M, Kapelak B. Final 5-year outcomes following aortic valve replacement with a RESILIA tissue bioprosthesis. Eur J Cardiothorac Surg. 2021 Jan 29;59(2):434-441. doi: 10.1093/ejcts/ezaa311.
Short Form Health Survey (SF-12) with 12 questions to measure functional health and well-being of patient's quality of lifeLink provided by the sponsor.

Related trials for Aortic Valve Disorder

Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic

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.

Jerzy Sadowski, MD principal investigator

John Paul II Hospital

Jacek Rozanski, MD principal investigator

The Cardinal Stefan Wyszyński Institute of Cardiology

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Heart Valve Surgery in people with Aortic Valve Disorder and Aortic Valve Insufficiency, run by Edwards Lifesciences at 2 sites in Poland.

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 4 inclusion and 7 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 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Poland. 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 26 Jul 2019). 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?

Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) (time frame: Events occurring 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 NCT01651052, 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 26 Jul 2019.