Edwards Bioprosthetic Heart Valves for Heart Valve Disease (COMMENCE Trial)

Recruiting in Palo Alto (17 mi)

+33 other locations

Overseen ByJohn Puskas, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Edwards Lifesciences

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

I am scheduled for aortic or mitral valve replacement, possibly with bypass surgery.

I am 18 years old or older.

I need a valve replacement for my heart based on my doctor's advice.

I am scheduled for aortic valve replacement surgery without needing to stop my circulation.

Exclusion Criteria

I need surgery that is not related to my heart.

I need surgery to replace the root of my aorta.

I have had heart inflammation or infection within the last 3 months.

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.

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 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.

My kidney function is low, with creatinine levels high or I am on chronic dialysis.

I need emergency surgery.

I have been diagnosed with abnormal calcium levels and overactive parathyroid glands.

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: Bioprosthesis: Aortic Model 11000A/ Mitral Model 11000MExperimental Treatment1 Intervention

Aortic/Mitral valve replacement therapy