Transcatheter Mitral Valve Replacement for Mitral Valve Disease

Not currently recruiting at 19 trial locations

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Edwards Lifesciences

Must not be taking: Antithrombotics, Anticoagulants

Disqualifiers: Severe lung disease, Severe pulmonary hypertension, Severe RV dysfunction, others

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

Compensation: Varies

Number of Visits: 2

Duration: Immediate procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new heart valve, the SAPIEN 3, to determine its safety and effectiveness for individuals with a failing mitral valve. The focus is on those whose previously implanted valve in the mitral position is malfunctioning, causing issues like narrowing or leaking. Potential participants have a mitral valve that no longer functions properly and experience symptoms affecting daily life, such as difficulty breathing or reduced activity levels. As an unphased trial, this study provides patients the opportunity to contribute to important research that could enhance treatment options for mitral valve issues.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you must be able to tolerate antithrombotic (blood-thinning) therapy during and after the procedure.

What prior data suggests that the SAPIEN 3 transcatheter heart valve is safe for patients with a failing mitral bioprosthetic valve?

Research has shown that the SAPIEN 3 heart valve is generally well-tolerated by patients. In a study involving 1,529 high-risk patients who received this valve for mitral valve replacement, the procedure succeeded in 96.8% of cases. Only 5.4% of patients died within 30 days after the procedure. The FDA has already approved the valve for treating aortic stenosis, which adds confidence in its safety. While all medical procedures carry risks, these results suggest that the SAPIEN 3 valve is relatively safe for patients needing mitral valve treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Edwards SAPIEN 3 transcatheter valve is unique because it offers a minimally invasive alternative to traditional open-heart surgery for patients with a failing bioprosthetic valve in the mitral position. Unlike standard surgical valve replacements, which require a large chest incision and lengthy recovery time, this valve is delivered using a catheter through a small incision, reducing recovery time significantly. Researchers are excited about this treatment as it provides a less invasive option, potentially leading to faster recovery and fewer complications for patients with mitral valve disease.

What evidence suggests that the SAPIEN 3 transcatheter valve is effective for mitral valve disease?

Research has shown that the Edwards SAPIEN 3 transcatheter valve performs well for patients with a failing mitral bioprosthetic valve. In a study of 1,529 high-risk patients who received this valve, the procedure succeeded in 96.8% of cases. Additionally, only 5.4% of patients died from any cause within 30 days after the procedure. The valve has proven to be a safe and practical option for replacing worn-out mitral valves. In this trial, participants with a failing mitral transcatheter valve will receive the Edwards SAPIEN 3 valve. These results suggest that the SAPIEN 3 valve could be a promising option for those needing mitral valve replacement. ^{2 4 6 7 8}

Who Is on the Research Team?

Mayra Guerrero, MD

Principal Investigator

Mayo Clinic

Alan Zajarias, MD

Principal Investigator

Washington University School of Medicine

Chris S. Malaisrie, MD

Principal Investigator

Northwestern University Feinberg School of Medicine

Are You a Good Fit for This Trial?

The PARTNER 3 Trial is for patients with a failing mitral valve from a previous surgery, who are at intermediate risk for heart surgery. They must have moderate to severe issues with their valve and symptoms of heart failure (NYHA Class ≥ II). Patients should not have serious kidney disease, recent strokes or heart attacks, life expectancy under 2 years, or be pregnant.

Inclusion Criteria

I have a surgical heart valve that is between 16.5 mm and 28.5 mm in size.

My heart valve replacement is not working properly.

The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) / Ethics Committee (EC) of the respective clinical site.

Exclusion Criteria

My right heart chamber is not working properly.

I have a valve in my heart that might affect a new mitral implant.

After the original valve surgery, there was still a high level of pressure in the heart.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients with a failing bioprosthetic valve in the mitral position are treated with the Edwards SAPIEN 3 transcatheter valve

Immediate procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pulmonary artery systolic pressure, NYHA functional class, KCCQ score, and mitral regurgitation

1 year

Multiple visits over 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Edwards SAPIEN 3 transcatheter valve, Model 9600TFX

Trial Overview This trial tests the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve in patients whose previously implanted surgical bioprosthetic mitral valves are no longer working properly.

How Is the Trial Designed?

Group I: Failing mitral transcatheter valve Experimental Treatment 1 Intervention

Patients with a failing bioprosthetic valve in the mitral position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN 3 transcatheter valve.

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

An 86-year-old patient with high surgical risks successfully received a transcatheter mitral valve implant using the Sapien 3 valve within a failed bioprosthetic valve, demonstrating a new treatment option for high-risk patients.

Post-procedure echocardiograms showed satisfactory results, and the patient was discharged without complications, indicating the safety and efficacy of this innovative approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transapical Transcatheter Mitral Valve-in-Valve Implantation Using an Edwards SAPIEN 3 Valve. He, C., Scalia, G., Walters, DL., et al.[2022]

The SAPIEN 3 transcatheter valve demonstrated high safety and efficacy, with 96.4% of patients experiencing none to mild paravalvular regurgitation and a low mortality rate of 2.1% when using the transfemoral approach.

This third-generation valve shows promise as a viable alternative to high- or intermediate-risk surgical options for severe aortic stenosis, particularly due to its improved ease of use and accuracy in positioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve. Webb, J., Gerosa, G., Lefèvre, T., et al.[2022]

Transcatheter mitral valve-in-valve implantation in four pediatric patients with dysfunctional bioprosthetic mitral valves showed significant improvement, with the mean transmitral gradient dropping from 19.75 mm Hg to 1 mm Hg after the procedure.

The procedure was performed safely, with patients experiencing improved functional class from NYHA class IV to class I, suggesting it is a viable alternative for high-risk patients who cannot undergo traditional surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Mitral Valve-in-Valve Implantation in Pediatric Patients. Al Nasef, M., Alsahari, A., Eltayeb, A., et al.[2022]

The Edwards SAPIEN transcatheter heart valve (THV) is considered noninferior to traditional surgical aortic valve replacement for high-risk operable patients, based on the high-risk arm of the PARTNER trial.

Despite some concerns about safety and trial misconduct, the FDA panel unanimously agreed that the benefits of the Edwards SAPIEN THV outweigh the risks, leading to its approval for use in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overview of the 2012 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting on the Edwards SAPIEN transcatheter heart valve for high-risk aortic stenosis patients. Barbash, IM., Dvir, D., Waksman, R.[2013]

The Edwards SAPIEN transcatheter heart valve demonstrated a high success rate of 97.1% in deployment among 36 patients with moderate to severe pulmonary regurgitation, indicating its effectiveness in this patient population.

At 6-month follow-up, 97% of patients experienced significant improvements in their condition, with most showing reduced pulmonary regurgitation and a notable increase in functional status, suggesting the procedure is both safe and beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous implantation of the Edwards SAPIEN transcatheter heart valve for conduit failure in the pulmonary position: early phase 1 results from an international multicenter clinical trial. Kenny, D., Hijazi, ZM., Kar, S., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03193801

NCT03193801 | PARTNER 3 Trial - Mitral Valve in Valve To assess the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in patients with a failing mitral bioprosthetic valve. Detailed Description. A ...

2. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf14/P140031S112B.pdf

FDA - Summary of Safety and Effectiveness Data The Edwards SAPIEN 3 and SAPIEN 3 Ultra THV System is indicated for patients with symptomatic heart disease due to failing (stenosed, insufficient, or combined) ...

3. withpower.com withpower.com/trial/phase-mitral-valve-insufficiency-1-2018-1c1dc

Transcatheter Mitral Valve Replacement for ... The Edwards SAPIEN 3 valve has been shown to be safe and feasible for use in treating degenerated bioprosthetic mitral valves, as demonstrated in a case of ...

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf14/P140031S085d.pdf

Edwards SAPIEN 3 Transcatheter Heart Valve System 1) The Edwards SAPIEN 3 Transcatheter Heart Valve System is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7391176/

One-Year Outcomes of Mitral Valve-in-Valve Using the ... In this cohort study of 1529 high-risk patients who received SAPIEN 3 MViV, procedural technical success was 96.8% and all-cause mortality was 5.4% at 30 days ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf14/P140031c.pdf

Edwards SAPIEN 3 Transcatheter Heart Valve with the ... The Edwards SAPIEN 3 Transcatheter Heart Valve (THV), model 9600TFX, and accessories are indicated for relief of aortic stenosis in patients with symptomatic ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf14/P140031S162B.pdf

Summary of Safety and Effectiveness Data (SSED) 1) The Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter. Heart Valve system is indicated for relief of aortic stenosis in patients ...

8. eifu.edwards.com eifu.edwards.com/eifu/5970f1a946e0fb00015e5f4c/DOC-0251232B.pdf

Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra ... Patients in the trial received a SAPIEN 3 transcatheter heart valve for symptomatic heart disease due to severe native calcific aortic stenosis who were ...