Edwards Bioprosthetic Heart Valves for Heart Valve Disease

(COMMENCE Trial)

Not currently recruiting at 36 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Edwards Lifesciences

Disqualifiers: Renal insufficiency, Stroke, Myocardial infarction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Baseline to Discharge

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to ensure that new methods of processing, sterilizing, and packaging heart valve replacements are safe and effective for those needing a new aortic or mitral valve. The focus is on testing Edwards Aortic and Mitral Bioprostheses Models, designed to replace faulty heart valves. It suits individuals diagnosed with aortic or mitral valve disease who are scheduled for valve replacement surgery, possibly with bypass surgery. As an unphased trial, this study allows participants to contribute to innovative heart valve replacement methods.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these bioprosthetic heart valves are safe for valve replacement therapy?

Research has shown that the Edwards Aortic and Mitral Bioprostheses, Models 11000A and 11000M, have undergone thorough study to ensure safety for patients requiring heart valve replacements. Made from animal tissue, these devices replace damaged or failing heart valves.

Previous studies indicate that patients generally accept these bioprostheses well. Positive outcomes have been reported up to seven years post-implantation, demonstrating long-term effectiveness.

Recent changes in processing, sterilization, and packaging have not revealed any new safety concerns, suggesting these updates do not introduce additional risks. Overall, existing evidence supports the safety of these heart valve devices for patients in need. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Edwards Bioprosthetic Heart Valves because they offer a promising alternative for heart valve disease treatment. Unlike traditional mechanical valves, which require lifelong blood-thinning medication, these bioprostheses are made from animal tissue, potentially reducing the risk of complications. Additionally, these valves are designed for both aortic and mitral valve replacement, providing versatility in treating different types of valve disease. The innovative design aims to improve durability and performance, giving patients a more natural heart function and improving their quality of life without the need for constant medication management.

What evidence suggests that the Edwards Bioprosthetic Heart Valves are effective for heart valve disease?

Research shows that the Edwards Aortic and Mitral Bioprostheses, Models 11000A and 11000M, effectively replace heart valves. Past studies have demonstrated that these replacements are safe and maintain stable heart function over time. Specifically, after seven years, the aortic valve model helped maintain normal heart function. Similarly, patients with the mitral valve model showed steady heart performance and safety in medium-term studies. These results support the effectiveness of these bioprosthetic valves in treating heart valve disease. Participants in this trial will receive either the aortic or mitral valve model as part of the study's treatment arm. ^{1 2 3 5 6}

Who Is on the Research Team?

John Puskas, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

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

Provides written informed consent prior to trial procedures

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.

Exclusion Criteria

Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial

I need surgery that is not related to my heart.

A heart ultrasound shows something abnormal inside the heart.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo aortic or mitral valve replacement therapy using the Edwards Pericardial Bioprostheses

Baseline to Discharge

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Long-term Monitoring

Participants are assessed for long-term outcomes such as structural valve deterioration and adverse events

Up to 3 years post-implant

What Are the Treatments Tested in This Trial?

Interventions

• Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M

Trial Overview 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.

How Is the Trial Designed?

Group I: Bioprosthesis: Aortic Model 11000A/ Mitral Model 11000M Experimental Treatment 1 Intervention

Aortic/Mitral valve replacement therapy

Who Is Running the Clinical Trial?

Edwards Lifesciences

Lead Sponsor

Trials

188

Recruited

67,500+

Founded

1958

Headquarters

Irvine, California, U.S.

Known For

Structural Heart Innovations

Top Products

SAPIEN Transcatheter Heart Valve, EVOQUE System, PASCAL Precision, SAPIEN M3

Todd Brinton

Edwards Lifesciences

Chief Medical Officer since 2023

MD from Stanford University

Bernard Zovighian

Edwards Lifesciences

Chief Executive Officer since 2023

MBA from INSEAD

Published Research Related to This Trial

The Edwards INTUITY Valve System demonstrated excellent safety and efficacy in a study of 500 patients with severe aortic stenosis, showing a low 30-day mortality rate of 0.8% and high overall survival rates of 94%, 89%, and 81% at 1, 3, and 5 years, respectively.

The valve exhibited good hemodynamic performance with mean gradients remaining stable over 5 years, although there was a notable 8.6% rate of new pacemaker implantation, indicating a need for careful monitoring post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermediate-term outcome of 500 consecutive rapid-deployment surgical aortic valve procedures†. Andreas, M., Coti, I., Rosenhek, R., et al.[2020]

Citations

1. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf15/P150048S012C.pdf

EDWARDS PERICARDIAL MITRAL BIOPROSTHESIS ... The clinical safety and effectiveness of the Edwards Pericardial. Mitral Bioprosthesis, Model 11000M was established based on the outcome data of the COMMENCE ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01757665

Study Details | NCT01757665 | ProspeCtive, nOn- ... The trial will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic ...

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf15/P150048S012B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The study objective is to characterize the safety and effectiveness of the Edwards Pericardial Mitral Bioprosthesis, Model 11000M. All. IDE ...

4. edwards.com edwards.com/healthcare-professionals/products-services/surgical-heart/inspiring-results

Inspiring results Seven-year outcomes following aortic valve replacement with a novel tissue bioprosthesis. ... Mitral Bioprosthesis with RESILIA tissue (model 11000M).

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10556809/

Mid-term outcomes of the COMMENCE trial investigating ... Mitral valve replacement patients implanted with a RESILIA tissue bioprosthesis had a good safety profile and clinically stable hemodynamic performance.

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/65/NCT01757665/Prot_SAP_001.pdf

CLINICAL INVESTIGATIONAL PLAN The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic ...