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.
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
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
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- 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.
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
Poland2 sites
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Krakow, 31-202
The Cardinal Stefan Wyszynski Institute of Cardiology
Warsaw, 04-628
Canada1 site
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, G1V 4G5
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)
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 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Puskas, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
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 28605428Johnston 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 32340804Bavaria 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 35065065Heimansohn 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 37808026Beaver 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 37778503Bavaria 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 38135262Thourani 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 39780838Salna 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 40748697Kaneko 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