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

Not Applicable

Active, not recruiting

Conditions: Aortic Valve Insufficiency
Mitral Valve Insufficiency
Heart Failure
Aortic Stenosis
Mitral Stenosis

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

Registration Number: NCT01757665

Lead Sponsor: Edwards Lifesciences

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.

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.

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 777

Inclusion Criteria

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

Exclusion criteria:

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
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

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bioprosthesis: Aortic Model 11000A/ Mitral Model 11000M	Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M	Aortic/Mitral valve replacement therapy

Primary Outcome Measures

Name	Time	Method
Subjects With Structural Valve Deterioration	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects With Early Adverse Events	Events occuring within 30 days of procedure	Number of subjects with early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100
Percentage of Late Adverse Events Divided by Late Patient Years	Events occurring >= 31 days and up through 3 years post-implant	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).

Trial Locations

Locations (32): University of Southern California
🇺🇸
Los Angeles, California, United States
Hospital of the University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Baylor College of Medicine
🇺🇸
Houston, Texas, United States
Cardiology, P.C.
🇺🇸
Birmingham, Alabama, United States
Pinnacle Health Cardiovascular Institute
🇺🇸
Mechanicsburg, Pennsylvania, United States
OhioHealth Research Institute
🇺🇸
Columbus, Ohio, United States
Michael E. DeBakey VA Medical Center
🇺🇸
Houston, Texas, United States
Krakowski Szpital Specjalistyczny im. Jana Pawla II
🇵🇱
Krakow, Poland
New York Presbyterian Hospital - Columbia University Medical Center
🇺🇸
New York, New York, United States
The Ohio State University Wexner Medical Center
🇺🇸
Columbus, Ohio, United States
Emory University Hospital Midtown
🇺🇸
Atlanta, Georgia, United States
Missouri Baptist Medical Center
🇺🇸
Saint Louis, Missouri, United States
Washington University/ Barnes Jewish Hospital
🇺🇸
Saint Louis, Missouri, United States
New York Weill Cornell Medical Center
🇺🇸
New York, New York, United States
Icahn School of Medicine at Mount Sinai
🇺🇸
New York, New York, United States
Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
Mount Sinai Morningside
🇺🇸
New York, New York, United States
The Heart Hospital of Baylor Plano
🇺🇸
Plano, Texas, United States
Board of Trustees of the Leland Stanford Junior University
🇺🇸
Stanford, California, United States
St. Vincent Heart Center of Indiana
🇺🇸
Indianapolis, Indiana, United States
Sutter Institute for Medical Research
🇺🇸
Sacramento, California, United States
Institut Universitaire de Cardiologie et de Pneumologie de Québec
🇨🇦
Quebec, Canada
Spectrum Health Hospital
🇺🇸
Grand Rapids, Michigan, United States
The Cardinal Stefan Wyszynski Institute of Cardiology
🇵🇱
Warsaw, Poland
Yale-New Haven
🇺🇸
New Haven, Connecticut, United States
Shands at the University of Florida
🇺🇸
Gainesville, Florida, United States
Florida Hospital
🇺🇸
Orlando, Florida, United States
University of Maryland, Baltimore
🇺🇸
Baltimore, Maryland, United States
North Mississippi Medical Center
🇺🇸
Tupelo, Mississippi, United States
St. Thomas Health
🇺🇸
Nashville, Tennessee, United States
University of Utah
🇺🇸
Salt Lake City, Utah, United States
University of Kansas Medical Center
🇺🇸
Kansas City, Kansas, United States