Percutaneous vs Surgical Mitral Valve Repair for Mitral Valve Regurgitation

(REVIVE Trial)

Overseen By Mary Zhang, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Heart Institute Research Corporation

Disqualifiers: Mixed mitral pathology, Acute ischemic MR, Age < 18, others

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

Compensation: Varies

Number of Visits: 1

Duration: 2 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to repair a leaky mitral valve in individuals with severe ischemic mitral regurgitation, a condition where the valve fails to close properly. One group will receive a less-invasive treatment called percutaneous mitral valve repair (also known as MitraClip or Transcatheter Mitral Valve Repair), while the other group will undergo traditional surgery to repair or replace the valve. The trial aims to determine which method is more effective, particularly for those also requiring heart bypass surgery. Individuals diagnosed with severe ischemic mitral regurgitation and confirmed reversible heart muscle issues may be suitable candidates for this trial. As an unphased trial, this study provides patients the chance to contribute to valuable research that could enhance treatment options for future patients.

Will I have to stop taking my current medications?

The trial protocol 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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that percutaneous mitral valve repair is generally safe for patients. This method is less invasive than traditional surgery and results in fewer hospital stays for heart failure and lower death rates. Patients who underwent this procedure experienced significant health improvements, including better performance on a six-minute walk test, indicating that the treatment is well-tolerated and enhances quality of life.

Regarding safety, data from the MitraClip procedure (a device used in this repair) consistently show it is safe over several years. Patients experience fewer unexpected hospital visits and a noticeable drop in death rates compared to traditional treatments.

For surgical mitral valve repair, the risks are usually higher, especially for patients with other heart issues. Surgery can significantly increase the risk of death, particularly in high-risk patients. This makes the less invasive percutaneous option appealing for many. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for mitral valve regurgitation because they offer less invasive options compared to traditional surgery. Percutaneous mitral valve repair is performed through a catheter, avoiding the need for open-heart surgery, which can mean a quicker recovery and less risk for some patients. Additionally, this method can be combined with coronary artery bypass grafting, potentially addressing multiple heart issues in one go. Meanwhile, traditional surgical mitral repair or replacement remains a reliable option, but the less invasive nature of the percutaneous approach is particularly appealing for patients who may not be ideal candidates for surgery.

What evidence suggests that this trial's treatments could be effective for mitral valve regurgitation?

This trial will compare two treatments for mitral valve regurgitation: percutaneous mitral valve repair and surgical mitral valve repair/replacement. Research has shown that percutaneous mitral valve repair, one of the treatments in this trial, can be a safe and effective option for patients at high surgical risk. Studies have found that this less invasive method can reduce the risk of death from any cause and improve physical activity levels. Patients undergoing this procedure often experience fewer hospital visits due to heart failure compared to those receiving only medication.

In contrast, surgical repair or replacement of the mitral valve, the other treatment option in this trial, is often performed during heart bypass surgery. Although surgery is effective, it carries a higher risk of complications, particularly for high-risk patients. Both treatments aim to address mitral valve issues, but percutaneous repair offers a promising alternative with potentially better safety for certain patients. ^{2 3 4 6 7}

Who Is on the Research Team?

Vincent Chan, MD, MPH

Principal Investigator

Ottawa Heart Institute Research Corporation

Are You a Good Fit for This Trial?

The REVIVE trial is for adults with severe ischemic mitral regurgitation and reversible myocardial ischemia. It's not for those under 18, with certain heart valve conditions, previous mitral repairs, or who can't undergo cardiopulmonary bypass.

Inclusion Criteria

My heart test shows reversible damage.

I have severe heart valve leakage as per the 2017 guidelines.

Exclusion Criteria

My heart valve condition is due to a mix of causes like infection or tissue issues.

My heart valve's shape is not right for MitraClip treatment.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either surgical mitral valve repair/replacement with coronary artery bypass grafting or percutaneous mitral repair followed by coronary artery bypass grafting

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of left ventricular remodeling and presence of recurrent MR

12 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Percutaneous mitral valve repair
• Surgical mitral valve repair/replacement

Trial Overview This study compares two treatments for ischemic MR in the context of coronary artery disease: surgical repair/replacement of the mitral valve possibly combined with bypass grafting versus a less invasive percutaneous repair followed by bypass grafting.

How Is the Trial Designed?

Group I: Percutaneous mitral repair Experimental Treatment 1 Intervention

Percutaneous mitral repair +/- coronary artery bypass grafting within 14 days of mitral repair.

Group II: Mitral valve surgery Active Control 1 Intervention

Surgical mitral valve surgery +/- coronary artery bypass grafting

Percutaneous mitral valve repair is already approved in United States, European Union for the following indications:

Approved in United States as MitraClip for:

• Severe primary degenerative mitral regurgitation in patients who are high-risk candidates for surgical repair
• Moderate-to-severe or severe mitral regurgitation in certain patients with heart failure symptoms who fail to respond to guideline-directed medical therapy

Approved in European Union as MitraClip for:

• Primary mitral regurgitation
• Secondary mitral regurgitation

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials

200

Recruited

95,800+

Published Research Related to This Trial

Transcatheter mitral valve replacement (TMVR) showed significantly better reduction of mitral regurgitation (MR) and greater symptomatic improvement compared to mitral valve transcatheter edge-to-edge repair (M-TEER) in patients with secondary mitral regurgitation, with 95.8% achieving residual MR ≤1+ after TMVR versus 68.8% after M-TEER.

Although TMVR had a higher tendency for post-procedural mortality at 30 days (6.8% vs. 3.8% for M-TEER), no significant differences in mortality were observed beyond 30 days, indicating that TMVR may be a more effective long-term treatment option despite initial risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter mitral valve replacement or repair for secondary mitral regurgitation: a propensity score-matched analysis. Ludwig, S., Kalbacher, D., Ali, WB., et al.[2023]

In a study of 124 patients with significant mitral regurgitation, the PASCAL transcatheter valve repair system showed a 75% survival rate and a 73% rate of freedom from heart failure hospitalization after 3 years, indicating its long-term efficacy.

The procedure successfully reduced mitral regurgitation to levels of 2+ or less in 93% of patients and improved heart function, with 89% achieving NYHA class I/II status, demonstrating both safety and effectiveness in treating this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-year outcomes for transcatheter repair in patients with mitral regurgitation from the CLASP study. Spargias, K., Lim, DS., Makkar, R., et al.[2023]

Surgical therapy is the recommended treatment for primary mitral regurgitation, while secondary mitral regurgitation offers various therapeutic options, highlighting the complexity of managing this condition.

Recent advancements in Transcatheter Mitral Valve Replacement (TMVR) therapy, along with established methods like Mitral Valve Transcatheter Edge-to-Edge Repair (M-TEER), provide new avenues for treatment in patients with severe symptomatic mitral regurgitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mitral valve: When conservative, when surgical, when interventional therapy?] Reith, S., Zhang, Y., Bach, C., et al.[2022]

In a study of 63 patients eligible for the Tendyne system, those who underwent transcatheter mitral valve replacement (TMVR) experienced a significant reduction in mitral regurgitation severity, with 94.1% achieving less than 1+ MR at discharge, and greater left ventricular reverse remodeling at 30 days compared to those treated with transcatheter edge-to-edge repair (TEER).

However, TMVR with the Tendyne system was associated with a higher 30-day mortality rate compared to TEER, although mortality rates between 30 days and one year were similar for both treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and outcomes of patients undergoing transcatheter mitral valve replacement with the Tendyne system. Wilde, N., Tanaka, T., Vij, V., et al.[2023]

In a study analyzing 14,923 transcatheter mitral valve repair (TMVr) procedures performed by 562 operators, it was found that higher operator experience significantly improved procedural success rates, with optimal success increasing from 63.9% to 75.1% as experience grew (p < 0.001).

Increased operator experience also led to shorter procedural times and fewer complications, with notable improvements observed after approximately 50 cases, suggesting that continued practice up to 200 cases further enhances outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Operator Experience and Outcomes of Transcatheter Mitral Valve Repair in the United States. Chhatriwalla, AK., Vemulapalli, S., Szerlip, M., et al.[2020]

In a study of 1,044 patients undergoing transcatheter edge-to-edge repair (TEER) for mitral regurgitation (MR), those with functional MR (a-FMR and v-FMR) experienced worse clinical outcomes compared to those with degenerative MR (DMR) over a 2-year period.

Despite similar rates of residual MR after the procedure, patients with a-FMR and v-FMR had significantly higher rates of all-cause mortality and heart failure hospitalization (31.5% and 42.3%, respectively) compared to 21.6% in the DMR group, indicating that the etiology of MR impacts long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes After Transcatheter Edge-to-Edge Mitral Valve Repair According to Mitral Regurgitation Etiology and Cardiac Remodeling. Yoon, SH., Makar, M., Kar, S., et al.[2022]

In a meta-analysis of 1581 patients undergoing transcatheter edge-to-edge repair (TEER) of the mitral valve, both PASCAL and MitraClip devices demonstrated high success rates (approximately 97%) and similar outcomes in reducing mitral regurgitation (MR) and improving patient symptoms.

The study found no significant differences in 30-day all-cause mortality or complication rates between the two devices, indicating that PASCAL is as effective and safe as MitraClip for treating severe mitral regurgitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Edge-to-Edge Transcatheter Mitral Valve Repair Using PASCAL vs. MitraClip: A Systematic Review and Meta-Analysis. Hosseini, K., Soleimani, H., Nasrollahizadeh, A., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2941130/

Percutaneous mitral valve repair using the edge-to- ... Conclusion. Percutaneous mitral valve repair using the edge-to-edge technique seems to be a safe and efficient alternative therapy for inoperable/high-risk ...

2. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.039285

Mitral Valve Transcatheter Edge‐to‐Edge Repair or ... The present study encompasses all available randomized data on M‐TEER at the longest follow‐up and shows likely reductions in all‐cause death, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1050173825000258

Transcatheter edge-to-edge repair for mitral regurgitation Whitlow, et al. Percutaneous mitral valve repair using the edge-to-edge technique: six-month results of the EVEREST Phase I clinical trial. J Am Coll Cardiol ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36752231/

Design and Rationale of the REPAIR MR Trial Background The current standard of care for the treatment of patients with primary mitral regurgitation (MR) is surgical mitral valve repair.

5. jacc.org jacc.org/doi/10.1016/S0735-1097%2825%2901442-1

SAFETY AND EFFICACY OF PERCUTANEOUS ... TMVR with MitraClip leads to significant reductions in all-cause mortality, unplanned HHF, and improvement in the 6-minute walk test, compared to medical ...

6. ahajournals.org ahajournals.org/doi/10.1161/JAHA.122.027504

Percutaneous MitraClip Device or Surgical Mitral Valve ... Incidence and in‐hospital safety outcomes of patients undergoing percutaneous mitral valve edge‐to‐edge repair using MitraClip: five‐year ...

7. nejm.org nejm.org/doi/full/10.1056/NEJMoa2300213

Five-Year Follow-up after Transcatheter Repair ... Transcatheter edge-to-edge repair of the mitral valve was safe and led to a lower rate of hospitalization for heart failure and lower all-cause mortality ...