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

• ClinicalTrials.gov Identifier: NCT01757665
• Recruitment Status: Active, not recruiting
• First Posted: December 31, 2012
• Last Update Posted: August 1, 2019
• Sponsor: Edwards Lifesciences
• Information provided by (Responsible Party): Edwards Lifesciences

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Aortic Stenosis; Mitral Stenosis; Aortic Valve Insufficiency; Mitral Valve Insufficiency; Heart Failure	Device: Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 777 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Study Start Date: December 2012
• Actual Primary Completion Date: August 2018
• Estimated Study Completion Date: February 2026

Arms and Interventions

Arm	Intervention/treatment
Experimental: Bioprosthesis: Aortic Model 11000A/ Mitral Model 11000M; Aortic/Mitral valve replacement therapy	Device: Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M; Implant of an aortic valve, Model 11000A or mitral valve, Model 11000M

Outcome Measures

Primary Outcome Measures :

1. Safety Endpoints [ Time Frame: When 800 patient years for the aortic valve position and 800 aortic patient years and 100 mitral patient years of cumulative follow up for the mitral valve position have been achieved. ]

   Descriptive information of early rates and late linearized rates of:

   • Structural valve deterioration
   • Thromboembolism
   • Valve thrombosis
   • All bleeding/hemorrhage
   • Major bleeding/hemorrhage
   • All paravalvular leak
   • Major paravalvular leak
   • Non-structural valve deterioration
   • Endocarditis
   • All cause mortality
   • Trial valve-related mortality
   • Trial valve-related reoperation
   • Explant
   • Hemolysis

Secondary Outcome Measures :

1. Effectiveness Endpoints [ Time Frame: Up to 5-Years at each scheduled follow-up visit ]
   • Clinically acceptable hemodynamic performance confirmed by core lab evaluation of echocardiography
   • New York Heart Association (NYHA) functional class compared to baseline
   • Change in Quality of Life questionnaire Short Form 12 version 2 (SF-12v2) from baseline/screening to POD 390

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Eligibility Criteria:

Inclusion Criteria:

1. Is 18 years or older
2. Provides written informed consent prior to trial procedures
3. 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
4. Diagnosed with aortic or mitral valve disease requiring valve replacement based on pre- operative evaluation
5. Scheduled to undergo planned aortic or mitral valve replacement with or without concomitant bypass surgery
6. 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

Exclusion criteria:

A subject meeting any of the following criteria shall be excluded:

1. Requires emergency surgery
2. Requires planned multiple valve replacement/ repair (with the exception of mitral valve replacement with tricuspid valve repair)
3. Has prior valve surgery, which included implant of a bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ
4. Requires a surgical procedure outside of the cardiac area (e.g. vascular bypass)
5. Requires surgical replacement of the aortic root
6. Has active endocarditis/myocarditis or endocarditis/myocarditis within 3 months to the scheduled aortic or mitral valve replacement surgery
7. 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
8. 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
9. Has acute myocardial infarction (MI) within 30 days prior to planned valve surgery
10. Has presence of non-cardiac disease limiting life expectancy to less than 12 months
11. Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM)
12. Diagnosed with abnormal calcium metabolism and hyperparathyroidism
13. Exhibits left ventricular ejection fraction ≤ 20% as validated by diagnostic procedure prior to planned valve surgery
14. Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation
15. Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery
16. 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
17. Has prior organ transplant or is currently an organ transplant candidate
18. Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial
19. Was previously implanted with trial device (Model 11000A or Model 11000M)
20. Pregnant (female subject of childbearing potential only), lactating or planning to become pregnant during the duration of participation in trial
21. Currently incarcerated or unable to give voluntary informed consent
22. Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant
23. Requires concomitant left ventricular assist device (LVAD) placement

Contacts and Locations

  Show 32 Study Locations

Sponsors and Collaborators

Edwards Lifesciences

Investigators

• Principal Investigator: John Puskas, MD; Icahn School of Medicine at Mount Sinai

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Edwards Lifesciences
• ClinicalTrials.gov Identifier: NCT01757665 History of Changes
• Other Study ID Numbers: 2012-02
• First Posted: December 31, 2012
• Last Update Posted: August 1, 2019
• Last Verified: July 2019

Keywords provided by Edwards Lifesciences:

Aortic valve replacement; Mitral valve replacement

Additional relevant MeSH terms:

Aortic Valve Stenosis; Mitral Valve Insufficiency; Aortic Valve Insufficiency; Mitral Valve Stenosis; Constriction, Pathologic; Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Valve Diseases; Ventricular Outflow Obstruction