Transcatheter Mitral Valve Replacement for Mitral Valve Disease

Recruiting at 18 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

53 Participants Needed

Trial Summary

What is the purpose of this trial?

To assess the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in patients with a failing mitral bioprosthetic valve.

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 data supports the effectiveness of the treatment Edwards SAPIEN 3 transcatheter valve, Model 9600TFX, for mitral valve disease?

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 transapical mitral valve-in-valve implantation. Additionally, it is an established method of treatment in adults for bioprosthetic mitral valve issues, indicating its effectiveness in similar conditions. ^{1 2 3 4 5}

Is the Edwards SAPIEN 3 transcatheter valve generally safe for use in humans?

The Edwards SAPIEN 3 transcatheter valve has been evaluated for safety in various heart conditions, including aortic and pulmonary valve issues. It has been found to be generally safe, with features designed to improve implantation and reduce complications, and has been approved by the FDA for certain high-risk patients. ^{2 4 5 6 7}

How is the Edwards SAPIEN 3 transcatheter valve treatment different from other treatments for mitral valve disease?

The Edwards SAPIEN 3 transcatheter valve is unique because it allows for a less invasive procedure compared to traditional open-heart surgery, making it suitable for high-risk patients. It is inserted through a catheter, which is a thin tube, and can be used in a 'valve-in-valve' procedure to replace a failing bioprosthetic valve without the need for a repeat sternotomy (chest opening surgery). ^{1 2 3 8 9}

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Postoperative Migration of an Edwards-SAPIEN XT Mitral Valve-in-Valve Treated With Direct Vision Implantation During Beating-Heart Bypass. [2016]

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

Transcatheter Mitral Valve-in-Valve Implantation in Pediatric Patients. [2022]

3. 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]

4. France pubmed.ncbi.nlm.nih.gov

Percutaneous Edwards SAPIEN valve implantation in the tricuspid position: case report and review of literature. [2012]

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

Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve. [2022]

6. United States 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. [2013]

7. United States 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. [2022]

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

Challenging Case of Transcatheter Mitral Valve-in-Valve-in-Valve Replacement. [2023]

9. Australia pubmed.ncbi.nlm.nih.gov

Transapical Transcatheter Mitral Valve-in-Valve Implantation Using an Edwards SAPIEN 3 Valve. [2022]