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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
Must not have
Requires a surgical procedure outside of the cardiac area (e.g. vascular bypass)
Requires surgical replacement of the aortic root
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post implant
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for aortic or mitral valve replacement, possibly with bypass surgery.
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I am 18 years old or older.
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need surgery that is not related to my heart.
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I need surgery to replace the root of my aorta.
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I have had heart inflammation or infection within the last 3 months.
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I have had heart valve surgery and still have an implanted device.
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My non-heart related illness may limit my life to under a year.
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I have been diagnosed with a thickened heart muscle that obstructs blood flow.
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My heart's pumping ability is very low, confirmed by a test before valve surgery.
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I haven't needed help with my breathing or heart function in the last 30 days.
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I have low white blood cells, anemia, or low platelets with a history of bleeding or clotting issues.
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I have had an organ transplant or am waiting for one.
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My kidney function is low, with creatinine levels high or I am on chronic dialysis.
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I need emergency surgery.
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I have been diagnosed with abnormal calcium levels and overactive parathyroid glands.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and one year post-implant
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and one year post-implant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Subjects With Structural Valve Deterioration
Secondary study objectives
Percentage of Late Adverse Events Divided by Late Patient Years
Percentage of Subjects With Early Adverse Events
Other study objectives
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 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Bioprosthesis: Aortic Model 11000A/ Mitral Model 11000MExperimental Treatment1 Intervention
Aortic/Mitral valve replacement therapy

Find a Location

Who is running the clinical trial?

Edwards LifesciencesLead Sponsor
182 Previous Clinical Trials
62,331 Total Patients Enrolled
John Puskas, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
4 Previous Clinical Trials
1,744 Total Patients Enrolled

Media Library

Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M (Bioprostheses) Clinical Trial Eligibility Overview. Trial Name: NCT01757665 — N/A
Aortic Regurgitation Research Study Groups: Bioprosthesis: Aortic Model 11000A/ Mitral Model 11000M
Aortic Regurgitation Clinical Trial 2023: Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M Highlights & Side Effects. Trial Name: NCT01757665 — N/A
Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M (Bioprostheses) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01757665 — N/A
~60 spots leftby Dec 2025
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