Aortic StenosisCOMMENCENCT01757665

ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE)

A study testing Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M in people with Aortic Stenosis and Mitral Stenosis, run by Edwards Lifesciences at 32 sites in 3 countries.

Completed

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

Official record

Search all trials

Trial summary

The objective of this trial is to confirm that the modifications to tissue processing, valve sterilization and packaging do not raise any new questions of safety and effectiveness in subjects who require replacement of their native or prosthetic aortic or mitral valve. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Aortic Stenosis, Mitral Stenosis, Aortic Valve Insufficiency
What is being tested?: Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 777 participants
Where: 32 sitesin 3 countries
Study dates: 11 Dec 2012to 23 Mar 2026
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

Is 18 years or older
Provides written informed consent prior to trial procedures
Agrees to attend all follow-up assessments for up to 5 years and is willing to comply with specified follow-up evaluations at clinical investigational sites that are participating in the COMMENCE trial and/or obtain the protocol-specified diagnostic tests at centers that are under the same IRB or the same healthcare system
Diagnosed with aortic or mitral valve disease requiring valve replacement based on pre- operative evaluation
Scheduled to undergo planned aortic or mitral valve replacement with or without concomitant bypass surgery
Scheduled to undergo planned aortic valve replacement with or without resection and replacement of the ascending aorta from the sinotubular junction and without the need for circulatory arrest for hemi arch or arch replacement

Who cannot join

A subject meeting any of the following criteria shall be excluded:
Requires emergency surgery
Requires planned multiple valve replacement/ repair (with the exception of mitral valve replacement with tricuspid valve repair)
Has prior valve surgery, which included implant of a bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ
Requires a surgical procedure outside of the cardiac area (e.g. vascular bypass)
Requires surgical replacement of the aortic root

Show all 24Show fewer

Has active endocarditis/myocarditis or endocarditis/myocarditis within 3 months to the scheduled aortic or mitral valve replacement surgery
Has renal insufficiency as determined by creatinine (S-Cr) level ≥ 2.5 mg/dL or end -stage renal disease requiring chronic dialysis at screening visit
Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months (180 days) prior to planned valve surgery
Has acute myocardial infarction (MI) within 30 days prior to planned valve surgery
Has presence of non-cardiac disease limiting life expectancy to less than 12 months
Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM)
Diagnosed with abnormal calcium metabolism and hyperparathyroidism
Exhibits left ventricular ejection fraction ≤ 20% as validated by diagnostic procedure prior to planned valve surgery
Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation
Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery
Documented leukopenia (WBC < 3.5x 10³/μL), acute anemia (Hgb < 10.0 gm/dL or 6 mmol/L) or thrombocytopenia (platelet count < 50x 10³/μL) accompanied by history of bleeding diathesis and coagulopathy
Has prior organ transplant or is currently an organ transplant candidate
Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial
Was previously implanted with trial device (Model 11000A or Model 11000M)
Pregnant (female subject of childbearing potential only), lactating or planning to become pregnant during the duration of participation in trial
Currently incarcerated or unable to give voluntary informed consent
Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant
Requires concomitant left ventricular assist device (LVAD) placement

Trial locations and contacts

32 sites in 3 countries.

Country

City, postcode or hospital

32 sites in 3 countries

United States29 sites

Emory University Hospital Midtown
Atlanta, Georgia, 30308
University of Maryland, Baltimore
Baltimore, Maryland, 21201
Cardiology, P.C.
Birmingham, Alabama, 35211
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
OhioHealth Research Institute
Columbus, Ohio, 43124
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Shands at the University of Florida
Gainesville, Florida, 32608
Spectrum Health Hospital
Grand Rapids, Michigan, 49503
Baylor College of Medicine
Houston, Texas, 77030
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, 46290
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Southern California
Los Angeles, California, 90033
Pinnacle Health Cardiovascular Institute
Mechanicsburg, Pennsylvania, 17050
St. Thomas Health
Nashville, Tennessee, 37205
Yale-New Haven
New Haven, Connecticut, 06519
New York Weill Cornell Medical Center
New York, New York, 10021
Mount Sinai Morningside
New York, New York, 10025
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
New York Presbyterian Hospital - Columbia University Medical Center
New York, New York, 10032
Florida Hospital
Orlando, Florida, 32803
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
The Heart Hospital of Baylor Plano
Plano, Texas, 75093
Sutter Institute for Medical Research
Sacramento, California, 95919
University of Utah
Salt Lake City, Utah, 84132
Missouri Baptist Medical Center
St Louis, Missouri, 36131
Washington University/ Barnes Jewish Hospital
St Louis, Missouri, 63110
Board of Trustees of the Leland Stanford Junior University
Stanford, California, 94305
North Mississippi Medical Center
Tupelo, Mississippi, 38801

Other trials in United States

Poland2 sites

Krakowski Szpital Specjalistyczny im. Jana Pawla II
Krakow, 31-202
The Cardinal Stefan Wyszynski Institute of Cardiology
Warsaw, 04-628

Other trials in Poland

Canada1 site

Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, G1V 4G5

Other trials in Canada

About this study

Official title: ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Aortic and Mitral Bioprostheses (Models 11000A and 11000M) With a New Tissue Treatment Platform (COMMENCE)

Read the detailed description

Multicenter, prospective, single arm trial - Up to seven hundred (700) aortic valve replacement (AVR) subjects and up to one hundred seventy-five (175) mitral valve replacement (MVR) subjects at up to forty (40) clinical sites will be enrolled. The trial will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valve. Patients will be followed and assessed after implant for up to 5 years.

Conditions: Aortic Stenosis, Mitral Stenosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency, Heart Failure
Being tested: Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M
Keywords: Aortic valve replacement, Mitral valve replacement
Medical subject headings: Aortic Valve Stenosis, Mitral Valve Stenosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency, Heart Failure

What participants receive

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

Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000MDevice
Implant of an aortic valve, Model 11000A or mitral valve, Model 11000M

Study groups in NCT01757665
Study group	Role	What they receive
Bioprosthesis: Aortic Model 11000A/ Mitral Model 11000M	Experimental	Aortic/Mitral valve replacement therapy Receives: Device: Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M

What is being measured

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

Subjects With Structural Valve Deterioration
The rate of implanted subjects that experience structural valve deterioration (SVD) of the trial valve by the time of the post operative day (POD) 390 follow-up visit. Structural valve deterioration includes dysfunction or deterioration intrinsic to the valve. Examples of SVD includes complications such as wear, fracture, calcification, leaflet tear.
Measured: 1 Year Post Implant

Secondary outcomes (2)

Percentage of Subjects With Early Adverse Events
Number of subjects with early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100
Measured: Events occuring within 30 days of procedure
Percentage of Late Adverse Events Divided by Late Patient Years
Number of late 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 3 years post-implant

Timeline

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

11 Dec 201223 Mar 2026

First posted31 Dec 2012 (estimated)
Study start11 Dec 2012
Primary completionAug 2017
Study completion23 Mar 2026

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 (9)Papers the sponsor has linked to this study.
Other trials for Aortic StenosisStudies 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: 777 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01757665
Sponsor's protocol ID: 2012-02
Acronym: COMMENCE
Status last verified: Apr 2026
First submitted: 18 Dec 2012
Last updated: 7 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: Individual participant data will not be available to other researchers.

Publications

Puskas JD, Bavaria JE, Svensson LG, Blackstone EH, Griffith B, Gammie JS, Heimansohn DA, Sadowski J, Bartus K, Johnston DR, Rozanski J, Rosengart T, Girardi LN, Klodell CT, Mumtaz MA, Takayama H, Halkos M, Starnes V, Boateng P, Timek TA, Ryan W, Omer S, Smith CR; COMMENCE Trial Investigators. The COMMENCE trial: 2-year outcomes with an aortic bioprosthesis with RESILIA tissue. Eur J Cardiothorac Surg. 2017 Sep 1;52(3):432-439. doi: 10.1093/ejcts/ezx158.
PubMed 28605428
Johnston DR, Griffith BP, Puskas JD, Bavaria JE, Svensson LG; COMMENCE Trial Investigators. Intermediate-term outcomes of aortic valve replacement using a bioprosthesis with a novel tissue. J Thorac Cardiovasc Surg. 2021 Nov;162(5):1478-1485. doi: 10.1016/j.jtcvs.2020.01.095. Epub 2020 Feb 21.
PubMed 32340804
Bavaria JE, Griffith B, Heimansohn DA, Rozanski J, Johnston DR, Bartus K, Girardi LN, Beaver T, Takayama H, Mumtaz MA, Rosengart TK, Starnes V, Timek TA, Boateng P, Ryan W, Cornwell LD, Blackstone EH, Borger MA, Pibarot P, Thourani VH, Svensson LG, Puskas JD; COMMENCE Trial Investigators. Five-year Outcomes of the COMMENCE Trial Investigating Aortic Valve Replacement With RESILIA Tissue. Ann Thorac Surg. 2023 Jun;115(6):1429-1436. doi: 10.1016/j.athoracsur.2021.12.058. Epub 2022 Jan 20.
PubMed 35065065
Heimansohn DA, Baker C, Rodriguez E, Takayama H, Dagenais F, Talton DS, Mumtaz MA, Pibarot P, Puskas JD; COMMENCE Trial Investigators. Mid-term outcomes of the COMMENCE trial investigating mitral valve replacement using a bioprosthesis with a novel tissue. JTCVS Open. 2023 Jun 2;15:151-163. doi: 10.1016/j.xjon.2023.05.008. eCollection 2023 Sep.
PubMed 37808026
Beaver T, Bavaria JE, Griffith B, Svensson LG, Pibarot P, Borger MA, Sharaf OM, Heimansohn DA, Thourani VH, Blackstone EH, Puskas JD; COMMENCE Trial Investigators. Seven-year outcomes following aortic valve replacement with a novel tissue bioprosthesis. J Thorac Cardiovasc Surg. 2024 Sep;168(3):781-791. doi: 10.1016/j.jtcvs.2023.09.047. Epub 2023 Sep 29.
PubMed 37778503
Bavaria JE, Mumtaz MA, Griffith B, Svensson LG, Pibarot P, Borger MA, Thourani VH, Blackstone EH, Puskas JD. Five-Year Outcomes After Bicuspid Aortic Valve Replacement With a Novel Tissue Bioprosthesis. Ann Thorac Surg. 2024 Jul;118(1):173-179. doi: 10.1016/j.athoracsur.2023.11.036. Epub 2023 Dec 21.
PubMed 38135262
Thourani VH, Puskas JD, Griffith B, Svensson LG, Pibarot P, Borger MA, Heimansohn D, Beaver T, Blackstone EH, Antonio ALM, Bavaria JE; COMMENCE Trial Investigators. Five-year comparison of clinical and echocardiographic outcomes of pure aortic stenosis with pure aortic regurgitation or mixed aortic valve disease in the COMMENCE trial. JTCVS Open. 2024 Sep 10;22:160-173. doi: 10.1016/j.xjon.2024.08.020. eCollection 2024 Dec.
PubMed 39780838
Salna M, Bavaria JE, Heimansohn D, Beaver T, Griffith B, Svensson LG, Pibarot P, Borger MA, Thourani VH, Blackstone EH, Cornwell LD, Puskas JD, Takayama H. Seven-Year Results for RESILIA Tissue in Bicuspid Aortic Valve Replacement Patients: Age and Valve Size Considerations. Interdiscip Cardiovasc Thorac Surg. 2025 Aug 5;40(8):ivaf176. doi: 10.1093/icvts/ivaf176.
PubMed 40748697
Kaneko T, Bavaria JE, Thourani VH, Johnston DR. Propensity-adjusted 8-year outcomes following bioprosthetic aortic valve replacement: The influence of novel anticalcification technology. JTCVS Open. 2025 Dec 15;29:101557. doi: 10.1016/j.xjon.2025.101557. eCollection 2026 Feb.
PubMed 41960126

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 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Aortic and Mitral Bioprostheses (Models 11000A and 11000M) With a New Tissue Treatment Platform (COMMENCE)
ClinicalTrials.gov ID: NCT01757665
Acronym / sponsor ID: COMMENCE / 2012-02
Conditions: Aortic Stenosis, Mitral Stenosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency, Heart Failure
Keywords: Aortic valve replacement, Mitral valve replacement
Study type: Interventional
Recruitment status: Completed
Enrolment: 777 participants (actual)
Lead sponsor: Edwards LifesciencesIndustry (pharma, biotech, devices)
Study start: 11 Dec 2012 (actual)
Primary completion: Aug 2017 (actual)
Study completion: 23 Mar 2026 (actual)
First posted: 31 Dec 2012 (estimated)
Results: Posted 27 Dec 2019

Clinical summary

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

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
Bioprosthesis: Aortic Model 11000A/ Mitral Model 11000M	Experimental	Device: Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000MAortic/Mitral 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 (6 listed)

Is 18 years or older
Provides written informed consent prior to trial procedures
Agrees to attend all follow-up assessments for up to 5 years and is willing to comply with specified follow-up evaluations at clinical investigational sites that are participating in the COMMENCE trial and/or obtain the protocol-specified diagnostic tests at centers that are under the same IRB or the same healthcare system
Diagnosed with aortic or mitral valve disease requiring valve replacement based on pre- operative evaluation
Scheduled to undergo planned aortic or mitral valve replacement with or without concomitant bypass surgery

Key exclusion criteria (24 listed)

Requires emergency surgery
Requires planned multiple valve replacement/ repair (with the exception of mitral valve replacement with tricuspid valve repair)
Has prior valve surgery, which included implant of a bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ
Requires a surgical procedure outside of the cardiac area (e.g. vascular bypass)
Requires surgical replacement of the aortic root

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
Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000MImplant of an aortic valve, Model 11000A or mitral valve, Model 11000M	Device	Bioprosthesis: Aortic Model 11000A/ Mitral Model 11000M

Primary outcome

Subjects With Structural Valve Deterioration
Time frame: 1 Year Post Implant
The rate of implanted subjects that experience structural valve deterioration (SVD) of the trial valve by the time of the post operative day (POD) 390 follow-up visit. Structural valve deterioration includes dysfunction or deterioration intrinsic to the valve. Examples of SVD includes complications such as wear, fracture, calcification, leaflet tear.

2 secondary outcomes

Percentage of Subjects With Early Adverse Events
Time frame: Events occuring within 30 days of procedure
Percentage of Late Adverse Events Divided by Late Patient Years
Time frame: Events occurring >= 31 days and up through 3 years post-implant

Results and safety

Results posted to the registry on 27 Dec 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
Edwards Pericardial Aortic Bioprosthesis, Model 11000A	694	0
Edwards Pericardial Mitral Bioprosthesis, Model 11000M	83	0

Primary outcome: Subjects With Structural Valve Deterioration

Time frame: 1 Year Post Implant. Count of participants. Unit: Participants

Measure	Edwards Pericardial Bioprosthesis, Models 11000A & 11000M n = 716
Value	1

Edwards Pericardial Bioprosthesis, Models 11000A & 11000M: percent of patients: 0.1

Population analysed: The outcome is reported for subjects who received the Model 11000A or Model 11000M device where data is available. The SVD result combines the aortic and mitral implanted subjects. The study was powered for the combined cohort for this endpoint as there would be too few mitral subjects to report the arms separately.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Edwards Pericardial Aortic Bioprosthesis, Model 11000A	317 of 689 (46%)	542 of 589 (92%)	26 of 689
Edwards Pericardial Mitral Bioprosthesis, Model 11000M	58 of 82 (70.7%)	66 of 82 (80.5%)	8 of 82

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 28605428Puskas JD, Bavaria JE, Svensson LG, Blackstone EH, Griffith B, Gammie JS, Heimansohn DA, Sadowski J, Bartus K, Johnston DR, Rozanski J, Rosengart T, Girardi LN, Klodell CT, Mumtaz MA, Takayama H, Halkos M, Starnes V, Boateng P, Timek TA, Ryan W, Omer S, Smith CR; COMMENCE Trial Investigators. The COMMENCE trial: 2-year outcomes with an aortic bioprosthesis with RESILIA tissue. Eur J Cardiothorac Surg. 2017 Sep 1;52(3):432-439. doi: 10.1093/ejcts/ezx158.
Results publication: PubMed 32340804Johnston DR, Griffith BP, Puskas JD, Bavaria JE, Svensson LG; COMMENCE Trial Investigators. Intermediate-term outcomes of aortic valve replacement using a bioprosthesis with a novel tissue. J Thorac Cardiovasc Surg. 2021 Nov;162(5):1478-1485. doi: 10.1016/j.jtcvs.2020.01.095. Epub 2020 Feb 21.
Results publication: PubMed 35065065Bavaria JE, Griffith B, Heimansohn DA, Rozanski J, Johnston DR, Bartus K, Girardi LN, Beaver T, Takayama H, Mumtaz MA, Rosengart TK, Starnes V, Timek TA, Boateng P, Ryan W, Cornwell LD, Blackstone EH, Borger MA, Pibarot P, Thourani VH, Svensson LG, Puskas JD; COMMENCE Trial Investigators. Five-year Outcomes of the COMMENCE Trial Investigating Aortic Valve Replacement With RESILIA Tissue. Ann Thorac Surg. 2023 Jun;115(6):1429-1436. doi: 10.1016/j.athoracsur.2021.12.058. Epub 2022 Jan 20.
Results publication: PubMed 37808026Heimansohn DA, Baker C, Rodriguez E, Takayama H, Dagenais F, Talton DS, Mumtaz MA, Pibarot P, Puskas JD; COMMENCE Trial Investigators. Mid-term outcomes of the COMMENCE trial investigating mitral valve replacement using a bioprosthesis with a novel tissue. JTCVS Open. 2023 Jun 2;15:151-163. doi: 10.1016/j.xjon.2023.05.008. eCollection 2023 Sep.
Results publication: PubMed 37778503Beaver T, Bavaria JE, Griffith B, Svensson LG, Pibarot P, Borger MA, Sharaf OM, Heimansohn DA, Thourani VH, Blackstone EH, Puskas JD; COMMENCE Trial Investigators. Seven-year outcomes following aortic valve replacement with a novel tissue bioprosthesis. J Thorac Cardiovasc Surg. 2024 Sep;168(3):781-791. doi: 10.1016/j.jtcvs.2023.09.047. Epub 2023 Sep 29.
Results publication: PubMed 38135262Bavaria JE, Mumtaz MA, Griffith B, Svensson LG, Pibarot P, Borger MA, Thourani VH, Blackstone EH, Puskas JD. Five-Year Outcomes After Bicuspid Aortic Valve Replacement With a Novel Tissue Bioprosthesis. Ann Thorac Surg. 2024 Jul;118(1):173-179. doi: 10.1016/j.athoracsur.2023.11.036. Epub 2023 Dec 21.
Results publication: PubMed 39780838Thourani VH, Puskas JD, Griffith B, Svensson LG, Pibarot P, Borger MA, Heimansohn D, Beaver T, Blackstone EH, Antonio ALM, Bavaria JE; COMMENCE Trial Investigators. Five-year comparison of clinical and echocardiographic outcomes of pure aortic stenosis with pure aortic regurgitation or mixed aortic valve disease in the COMMENCE trial. JTCVS Open. 2024 Sep 10;22:160-173. doi: 10.1016/j.xjon.2024.08.020. eCollection 2024 Dec.
Results publication: PubMed 40748697Salna M, Bavaria JE, Heimansohn D, Beaver T, Griffith B, Svensson LG, Pibarot P, Borger MA, Thourani VH, Blackstone EH, Cornwell LD, Puskas JD, Takayama H. Seven-Year Results for RESILIA Tissue in Bicuspid Aortic Valve Replacement Patients: Age and Valve Size Considerations. Interdiscip Cardiovasc Thorac Surg. 2025 Aug 5;40(8):ivaf176. doi: 10.1093/icvts/ivaf176.
Results publication: PubMed 41960126Kaneko T, Bavaria JE, Thourani VH, Johnston DR. Propensity-adjusted 8-year outcomes following bioprosthetic aortic valve replacement: The influence of novel anticalcification technology. JTCVS Open. 2025 Dec 15;29:101557. doi: 10.1016/j.xjon.2025.101557. eCollection 2026 Feb.
New York Heart Association ClassificationLink provided by the sponsor.
Individual participant dataSharing planned: No. Individual participant data will not be available to other researchers.

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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.

John Puskas, MD principal investigator

Icahn School of Medicine at Mount Sinai

32 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M in people with Aortic Stenosis and Mitral Stenosis, run by Edwards Lifesciences at 32 sites in 3 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 6 inclusion and 24 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 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States, Poland, Canada. 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 27 Dec 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?

Subjects With Structural Valve Deterioration (time frame: 1 Year Post Implant). 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 NCT01757665, which also lists 9 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 7 May 2026.