Mitral Valve Replacement for Mitral Valve Regurgitation

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new mitral valve replacement system called the Edwards EVOQUE Eos to determine its safety and effectiveness for individuals with mitral valve regurgitation. This condition occurs when the heart's mitral valve fails to close tightly, causing blood to flow backward in the heart. The trial seeks participants who experience noticeable symptoms from this condition and face high risks with open-heart surgery. Individuals with a heart shape incompatible with the new valve or those unable to undergo surgery cannot join. As an unphased trial, this study provides a unique opportunity to contribute to medical advancements and potentially benefit from a novel treatment.

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 prior data suggests that the Edwards EVOQUE Eos mitral valve replacement system is safe?

Research has shown that the Edwards EVOQUE Eos Mitral Valve Replacement System offers promising safety results. In one study involving 50 patients, 14% did not survive past 30 days, but the procedure succeeded in 98% of cases, indicating that most patients had their valve replaced without major issues. Another study found success in all cases, with 98% of patients experiencing a significant reduction in the severity of their leaking heart valve just 30 days after the procedure. These findings suggest that the treatment is generally well-tolerated, though some risks remain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Edwards EVOQUE Eos Mitral Valve Replacement System is unique because it introduces a minimally invasive approach to replacing the mitral valve, which could be a game-changer for patients with mitral valve regurgitation. Unlike traditional open-heart surgery, which is the standard treatment, this system is designed to be delivered via a catheter, reducing the need for major surgery and potentially speeding up recovery time. Researchers are excited about this innovation because it could offer a safer and less invasive alternative for patients who are at high risk for surgical complications.

What evidence suggests that the Edwards EVOQUE Eos mitral valve replacement system is effective for mitral valve regurgitation?

Research shows that the Edwards EVOQUE Eos mitral valve replacement system, which participants in this trial will receive, holds promise for treating mitral valve regurgitation, a condition where the heart's mitral valve doesn't close tightly. In a study with 50 patients, 98% experienced significant improvement in their condition just 30 days after the procedure. The procedure succeeded in 96% of cases, with the valve placed correctly and functioning well. Patients reported feeling much better, making this treatment a strong option for those with this heart issue. Overall, these findings support the effectiveness of the Edwards EVOQUE Eos system in helping patients with mitral valve problems. ^{1 2 3 5 6}

Who Is on the Research Team?

Rajendra Makkar, MD

Principal Investigator

Cedars-Sinai Medical Center, Los Angeles, CA

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02718001

NCT02718001 | Edwards EVOQUE Eos MISCEND Study The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the Edwards EVOQUE Eos mitral ...

2. tandfonline.com tandfonline.com/doi/full/10.1080/17434440.2025.2561242?src=

Device profile of the EVOQUE Eos system for transcatheter ... The EVOQUE Eos system demonstrated the feasibility of a fully transseptal, retrievable transcatheter mitral valve replacement (TMVR) system in high-risk ...

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.125.015298

TMVR for the Treatment of Mitral Regurgitation: A State-of- ... In the first pilot trial (50 patients), the 30-day mortality rate was 14%, with a procedural success rate of 98% and mild or no residual MR ...

4. withpower.com withpower.com/trial/phase-mitral-valve-insufficiency-1-2015-4f021

Mitral Valve Replacement for Mitral Valve Regurgitation At 30 days post-procedure, 98% of patients experienced a significant reduction in mitral regurgitation severity, and there were notable improvements in ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10198241/

Transcatheter Mitral Valve Replacement with Dedicated ... According to the Mitral Valve Academic Research Consortium definitions, technical success was achieved in 96% of the patients, along with 94% ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40992807/

1-Year Outcomes of Transfemoral Transcatheter Mitral ... Device and procedural success rates were 100.0%. ... The rate of MR ≤1+ was 98.1% at 30 days and 100.0% at 1 year, with none/trace MR in 63.0% and ...