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

Primary Purpose

Aortic Stenosis, Mitral Stenosis, Aortic Valve Insufficiency

Status

Active

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M

About this trial

This is an interventional treatment trial for Aortic Stenosis focused on measuring Aortic valve replacement, Mitral valve replacement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Eligibility Criteria:

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

Sites / Locations

Cardiology, P.C.
University of Southern California
Sutter Institute for Medical Research
Board of Trustees of the Leland Stanford Junior University
Yale-New Haven
Shands at the University of Florida
Florida Hospital
Emory University Hospital Midtown
St. Vincent Heart Center of Indiana
University of Kansas Medical Center
University of Maryland, Baltimore
Spectrum Health Hospital
North Mississippi Medical Center
Missouri Baptist Medical Center
Washington University/ Barnes Jewish Hospital
New York Weill Cornell Medical Center
Mount Sinai Morningside
Icahn School of Medicine at Mount Sinai
New York Presbyterian Hospital - Columbia University Medical Center
Cleveland Clinic Foundation
OhioHealth Research Institute
The Ohio State University Wexner Medical Center
Pinnacle Health Cardiovascular Institute
Hospital of the University of Pennsylvania
St. Thomas Health
Baylor College of Medicine
Michael E. DeBakey VA Medical Center
The Heart Hospital of Baylor Plano
University of Utah
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Krakowski Szpital Specjalistyczny im. Jana Pawla II
The Cardinal Stefan Wyszynski Institute of Cardiology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bioprosthesis: Aortic Model 11000A/ Mitral Model 11000M

Arm Description

Aortic/Mitral valve replacement therapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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).

Full Information

NCT ID

NCT01757665

First Posted

December 18, 2012

Last Updated

January 23, 2023

Sponsor

Edwards Lifesciences

1. Study Identification

Unique Protocol Identification Number

NCT01757665

Brief Title

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

Acronym

COMMENCE

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 Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 11, 2012 (Actual)

Primary Completion Date

August 2017 (Actual)

Study Completion Date

August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Edwards Lifesciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Stenosis, Mitral Stenosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency, Heart Failure

Keywords

Aortic valve replacement, Mitral valve replacement

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

777 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bioprosthesis: Aortic Model 11000A/ Mitral Model 11000M

Arm Type

Experimental

Arm Description

Aortic/Mitral valve replacement therapy

Intervention Type

Device

Intervention Name(s)

Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M

Intervention Description

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

Primary Outcome Measure Information:

Title

Subjects With Structural Valve Deterioration

Description

Time Frame

1 Year Post Implant

Secondary Outcome Measure Information:

Title

Percentage of Subjects With Early Adverse Events

Description

Number of subjects with early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100

Time Frame

Events occuring within 30 days of procedure

Title

Percentage of Late Adverse Events Divided by Late Patient Years

Description

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Subject's Average Mean Gradient Measurements - 11000A

Description

Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.

Time Frame

3 Months, 1 Year, and 2 Year Post Implant

Title

Subject's Average Mean Gradient Measurements - 11000M

Description

Mean gradient is the average flow of blood through the mitral valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.

Time Frame