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Bioprostheses
Edwards Bioprosthetic Heart Valves for Heart Valve Disease (COMMENCE Trial)
N/A
Waitlist Available
Led By John Puskas, MD
Research Sponsored by Edwards Lifesciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Scheduled to undergo planned aortic or mitral valve replacement with or without concomitant bypass surgery
Is 18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post implant
Awards & highlights
COMMENCE Trial Summary
This trial is to confirm that 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.
Who is the study for?
Adults needing aortic or mitral valve replacement due to heart valve disease can join this trial. They must consent to follow-up for 5 years and be able to attend assessments. Excluded are those with recent strokes, heart attacks, life-limiting diseases, severe heart failure, organ transplants, other trial participation, pregnancy plans during the trial period, multiple valve replacements/repairs outside of specified conditions or certain blood disorders.Check my eligibility
What is being tested?
The COMMENCE trial is testing Edwards Bioprostheses Models 11000A (aortic) and 11000M (mitral) in patients requiring valve replacement. It aims to ensure that changes in tissue processing and sterilization do not affect safety or effectiveness over five years post-surgery.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks of valve replacement surgery may include bleeding, infection at the incision site, blood clots leading to stroke or lung problems; irregular heartbeat; kidney failure; heart attack; pneumonia; and rarely death.
COMMENCE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for aortic or mitral valve replacement, possibly with bypass surgery.
Select...
I am 18 years old or older.
Select...
I need a valve replacement for my heart based on my doctor's advice.
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I am scheduled for aortic valve replacement surgery without needing to stop my circulation.
COMMENCE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and one year post-implant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and one year post-implant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Subjects With Structural Valve Deterioration
Secondary outcome measures
Percentage of Late Adverse Events Divided by Late Patient Years
Percentage of Subjects With Early Adverse Events
Other outcome measures
Subject's Amount of Paravalvular Leak Over Time - 11000A
Subject's Amount of Paravalvular Leak Over Time - 11000M
Subject's Amount of Total Valvular Regurgitation Over Time - 11000A
+27 moreCOMMENCE Trial Design
1Treatment groups
Experimental Treatment
Group I: Bioprosthesis: Aortic Model 11000A/ Mitral Model 11000MExperimental Treatment1 Intervention
Aortic/Mitral valve replacement therapy
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Who is running the clinical trial?
Edwards LifesciencesLead Sponsor
180 Previous Clinical Trials
61,613 Total Patients Enrolled
2 Trials studying Mitral Valve Stenosis
625 Patients Enrolled for Mitral Valve Stenosis
John Puskas, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
4 Previous Clinical Trials
1,744 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need surgery that is not related to my heart.A heart ultrasound shows something abnormal inside the heart.I am 18 years old or older.My heart's pumping ability is very low, confirmed by a test before valve surgery.I haven't needed help with my breathing or heart function in the last 30 days.I need surgery to replace the root of my aorta.I have had heart inflammation or infection within the last 3 months.I've had a stroke or mini-stroke confirmed by MRI or CT scan in the last 6 months.I am scheduled for aortic or mitral valve replacement, possibly with bypass surgery.I need a valve replacement for my heart based on my doctor's advice.I have had heart valve surgery and still have an implanted device.My non-heart related illness may limit my life to under a year.I have been diagnosed with a thickened heart muscle that obstructs blood flow.I have low white blood cells, anemia, or low platelets with a history of bleeding or clotting issues.I have had an organ transplant or am waiting for one.I am scheduled for aortic valve replacement surgery without needing to stop my circulation.My kidney function is low, with creatinine levels high or I am on chronic dialysis.You need to have a device called a left ventricular assist device (LVAD) put in at the same time.I need emergency surgery.I had a heart attack within the last 30 days before my planned valve surgery.You have had a specific trial device called Model 11000A or Model 11000M implanted before.I need surgery to repair or replace more than one heart valve, except for mitral and tricuspid valves together.I have been diagnosed with abnormal calcium levels and overactive parathyroid glands.You have a record of using drugs or drinking too much alcohol in the last 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: Bioprosthesis: Aortic Model 11000A/ Mitral Model 11000M
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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