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

NCT01757665 | Active Not Recruiting Results DMC FDA Device

• 1 other identifier: 2012-02
• Study Type: interventional
• Target: 777
• Locations: 3 countries
• Sites: 32

Brief 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.

Conditions

Aortic Stenosis; Mitral Stenosis; Aortic Valve Insufficiency; Mitral Valve Insufficiency; Heart Failure

Keywords

Aortic valve replacement; Mitral valve replacement

Outcome Measures

Primary Outcomes (1)

• 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.

  1 Year Post Implant

Secondary Outcomes (2)

• Percentage of Subjects With Early Adverse Events

  Events occuring within 30 days of procedure

• Percentage of Late Adverse Events Divided by Late Patient Years

  Events occurring >= 31 days and up through 3 years post-implant

Other Outcomes (30)

• Subject's Average Mean Gradient Measurements - 11000A

  3 Months, 1 Year, and 2 Year Post Implant

• Subject's Average Mean Gradient Measurements - 11000M

  3 Months, 1 Year, and 2 Years Post Implant

• Subject's Average Peak Gradients Measurements Over Time - 11000A

  3 Months, 1 Year, and 2 Years Post Implant

Study Arms (1)

Bioprosthesis: Aortic Model 11000A/ Mitral Model 11000M

EXPERIMENTAL

Aortic/Mitral valve replacement therapy

Device: Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M

Interventions

Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M DEVICE

Implant of an aortic valve, Model 11000A or mitral valve, Model 11000M

Bioprosthesis: Aortic Model 11000A/ Mitral Model 11000M

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (32)

Cardiology, P.C.

Birmingham, Alabama, 35211, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Sutter Institute for Medical Research

Sacramento, California, 95919, United States

Location

Board of Trustees of the Leland Stanford Junior University

Stanford, California, 94305, United States

Location

Yale-New Haven

New Haven, Connecticut, 06519, United States

Location

Shands at the University of Florida

Gainesville, Florida, 32608, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

St. Vincent Heart Center of Indiana

Indianapolis, Indiana, 46290, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

Spectrum Health Hospital

Grand Rapids, Michigan, 49503, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

Missouri Baptist Medical Center

St Louis, Missouri, 36131, United States

Location

Washington University/ Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

New York Weill Cornell Medical Center

New York, New York, 10021, United States

Location

Mount Sinai Morningside

New York, New York, 10025, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

New York Presbyterian Hospital - Columbia University Medical Center

New York, New York, 10032, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

OhioHealth Research Institute

Columbus, Ohio, 43124, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Pinnacle Health Cardiovascular Institute

Mechanicsburg, Pennsylvania, 17050, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

St. Thomas Health

Nashville, Tennessee, 37205, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

The Heart Hospital of Baylor Plano

Plano, Texas, 75093, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, G1V 4G5, Canada

Location

Krakowski Szpital Specjalistyczny im. Jana Pawla II

Krakow, 31-202, Poland

Location

The Cardinal Stefan Wyszynski Institute of Cardiology

Warsaw, 04-628, Poland

Location

Related Publications (8)

• 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.

  PMID: 28605428 RESULT

• 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.

  PMID: 32340804 RESULT

• 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.

  PMID: 35065065 RESULT

• 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.

  PMID: 37808026 RESULT

• 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.

  PMID: 37778503 RESULT

• 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.

  PMID: 38135262 RESULT

• 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.

  PMID: 39780838 RESULT

• 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.

  PMID: 40748697 RESULT

Related Links

• New York Heart Association Classification
• Short Form Health Survey (SF-12)

MeSH Terms

Conditions

Aortic Valve Stenosis; Mitral Valve Stenosis; Aortic Valve Insufficiency; Mitral Valve Insufficiency; Heart Failure

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Results Point of Contact

• Title: Aya Westbrook, PhD, Director of Clinical Program Management
• Organization: Edwards Lifesciences, LLC

aya_westbrook@edwards.com

949-250-2500

Study Officials

• John Puskas, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2012
• First Posted: December 31, 2012
• Study Start: December 11, 2012
• Primary Completion: August 1, 2017
• Study Completion (Estimated): August 1, 2026
• Last Updated: November 17, 2025
• Results First Posted: December 27, 2019

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (29); PL (2); CA (1)