Mitral Valve Replacement for Mitral Valve Regurgitation

Recruiting at 18 trial locations

Overseen By TMTT Clinical

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Edwards Lifesciences

Disqualifiers: Unsuitable anatomy, Inoperable, others

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

Compensation: Varies

Number of Visits: 31

Duration: Immediately after procedure

123 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.

What data supports the effectiveness of the treatment Edwards EVOQUE Eos Mitral Valve Replacement System for Mitral Valve Regurgitation?

Early studies show that the Evoque system, used for patients too high-risk for surgery, has promising results in treating mitral regurgitation, a condition where the heart's mitral valve doesn't close tightly, allowing blood to flow backward in the heart. ^{1 2 3 4 5}

How is the Edwards EVOQUE Eos Mitral Valve Replacement System treatment different from other treatments for mitral valve regurgitation?

The Edwards EVOQUE Eos Mitral Valve Replacement System is a transcatheter treatment, meaning it is minimally invasive and can be an option for patients who are at high risk for traditional surgery. This system is part of a new wave of devices specifically designed for mitral valve replacement, offering a less invasive alternative to open-heart surgery. ^{1 2 5 6 7}

What is the purpose of this trial?

This trial is testing a new device that replaces a damaged heart valve in patients whose mitral valve is not working properly. The new valve helps the heart pump blood more effectively. The Evalve Mitraclip, a device for percutaneous mitral valve repair, is currently being tested.

Research Team

Rajendra Makkar, MD

Principal Investigator

Cedars-Sinai Medical Center, Los Angeles, CA

Eligibility Criteria

This trial is for individuals with severe, symptomatic mitral valve regurgitation who are at high risk for open-heart surgery but meet specific anatomical criteria. It's not suitable for those considered inoperable or with unsuitable anatomy.

Inclusion Criteria

I have serious symptoms from a leaky heart valve.

My body meets the specific physical requirements.

I am considered high risk for open-heart surgery.

Exclusion Criteria

My body's structure makes me ineligible for the procedure.

My condition cannot be treated with surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Edwards EVOQUE Eos mitral valve replacement system

Immediately after procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Multiple visits (in-person) at 30 days, 6 months, 12 months, and annually

Treatment Details

Interventions

• Edwards EVOQUE Eos Mitral Valve Replacement System

Trial Overview The study is testing the Edwards EVOQUE Eos Mitral Valve Replacement System to assess its safety and performance as a treatment option for mitral valve regurgitation.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

Treatment with the Edwards EVOQUE Eos mitral valve replacement system

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

Surgical intervention for severe functional mitral regurgitation is effective and can be performed using traditional or minimally invasive techniques, both yielding similar outcomes for patients who are suitable for surgery.

Transcatheter mitral valve replacement is a promising new technology for patients at high surgical risk, with early studies on devices like Tendyne, Intrepid, and Evoque showing encouraging results in treating mitral regurgitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical versus transcatheter mitral valve replacement in functional mitral valve regurgitation. Scott, EJ., Rotar, EP., Charles, EJ., et al.[2022]

The novel Cephea transcatheter mitral valve replacement system demonstrated excellent biological performance and safety in a preclinical model, with all 10 sheep surviving the study without complications and showing no signs of thrombosis or excessive calcification.

The transseptal delivery method was feasible and effective in pigs, with stable valve positioning and good hemodynamic profiles confirmed through echocardiography and autopsy, suggesting potential for future human applications in treating severe mitral regurgitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experimental Evaluation of a Novel Percutaneous Transseptal Catheter-Based Mitral Valve Replacement Technology. Vahl, TP., Grogan, A., Cheng, Y., et al.[2020]

The PASCAL Transcatheter Valve Repair System demonstrated a low major adverse event rate of 6.5% and an all-cause mortality rate of only 1.6% in 62 patients with severe mitral regurgitation, indicating its safety for use in this population.

At 30 days post-procedure, 98% of patients experienced a significant reduction in mitral regurgitation severity, and there were notable improvements in functional status and quality of life, as evidenced by increased walking distance and higher scores on quality of life assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Valve Repair for Patients With Mitral Regurgitation: 30-Day Results of the CLASP Study. Lim, DS., Kar, S., Spargias, K., et al.[2020]

References

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

Transcatheter Mitral Valve Replacement with Dedicated Devices. [2023]

2. China pubmed.ncbi.nlm.nih.gov

Surgical versus transcatheter mitral valve replacement in functional mitral valve regurgitation. [2022]

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

Experimental Evaluation of a Novel Percutaneous Transseptal Catheter-Based Mitral Valve Replacement Technology. [2020]

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

Mitral valve repair or replacement for ischemic mitral regurgitation? The Italian Study on the Treatment of Ischemic Mitral Regurgitation (ISTIMIR). [2022]

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

Transcatheter Mitral Valve Replacement for Degenerated Bioprosthetic Valves and Failed Annuloplasty Rings. [2020]

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

Premature Bioprosthetic Mitral Valve Dysfunction Due to Flail Leaflet Treated With Transcatheter Mitral Valve Replacement; a Case Report. [2022]

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

Transcatheter Valve Repair for Patients With Mitral Regurgitation: 30-Day Results of the CLASP Study. [2020]