Edwards Bioprosthetic Heart Valves for Heart Valve Disease

(COMMENCE Trial)

Recruiting at 33 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

777 Participants Needed

Trial Summary

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 data supports the effectiveness of the Edwards Bioprosthetic Heart Valves treatment for heart valve disease?

The Carpentier-Edwards bioprostheses have shown good survival rates and low complication rates, such as thromboembolism (blood clots) and endocarditis (heart valve infection), in patients who received these valves for aortic and mitral valve replacements. This suggests that the Edwards bioprosthetic heart valves are effective for treating heart valve disease. ^{1 2 3 4 5}

Is the Edwards Bioprosthetic Heart Valve safe for humans?

The Edwards Bioprosthetic Heart Valve has been used in many patients with generally low rates of complications like valve failure, blood clots, and infections. Studies show good survival rates and low complication rates over several years, making it a safe option for heart valve replacement. ^{3 6 7 8 9}

How is the Edwards Bioprosthetic Heart Valve treatment different from other treatments for heart valve disease?

The Edwards Bioprosthetic Heart Valves, specifically the Edwards Aortic and Mitral Bioprostheses, are unique because they use a rapid-deployment system with a balloon-expandable stent frame, allowing for quicker and potentially less invasive valve replacement compared to traditional surgical methods. ^{10 11 12 13 14}

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.

Research Team

John Puskas, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

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

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Clinical comparative study between mitral mechanical and bioprosthetic valves--what is the benefit of bioprosthetic valves in the mitral position? [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

Carpentier-Edwards bioprosthesis: a 7-year follow-up in 361 patients. [2004]

3. United States pubmed.ncbi.nlm.nih.gov

An eight-year experience with porcine bioprosthetic cardiac valves. [2006]

4. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[10 years' experience of heart valve bioprostheses. Present status and future development]. [2016]

5. Germany pubmed.ncbi.nlm.nih.gov

Mitral valve disease: if the mitral valve is not reparable/failed repair, is bioprosthesis suitable for replacement? [2008]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Porcine cardiac bioprostheses: evaluation of long-term results in 990 patients. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Risk of thromboembolism with the aortic Carpentier-Edwards bioprosthesis. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

European experience with the second-generation Edwards SAPIEN XT transcatheter heart valve in patients with severe aortic stenosis: 1-year outcomes from the SOURCE XT Registry. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Long-Term Clinical Outcomes of the Carpentier-Edwards Perimount Pericardial Bioprosthesis in Chinese Patients with Single or Multiple Valve Replacement in Aortic, Mitral, or Tricuspid Positions. [2018]

10. Germany pubmed.ncbi.nlm.nih.gov

Intermediate-term outcome of 500 consecutive rapid-deployment surgical aortic valve procedures†. [2020]

11. China pubmed.ncbi.nlm.nih.gov

Outcome of rapid deployment aortic valves: long-term experience after 700 implants. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Insertion of an Edwards Sapien 3 prosthesis as a mitral valve in valve implantation via a transapical approach. [2017]

13. United States pubmed.ncbi.nlm.nih.gov

Transcatheter aortic valve implantation for treatment of failing homograft with preexisting mechanical mitral prosthesis. [2013]

14. Korea (South) pubmed.ncbi.nlm.nih.gov

Comparable Outcomes of Bicuspid Aortic Valves for Rapid-Deployment Aortic Valve Replacement. [2023]