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

Trial Summary

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.

What data supports the effectiveness of the treatment Percutaneous mitral valve repair, MitraClip, Transcatheter Mitral Valve Repair (TMVr), Transcatheter Edge-to-Edge Repair (TEER), Surgical mitral valve repair/replacement, Mitral valve repair, Mitral valve replacement, Surgical mitral valve repair, Surgical mitral valve replacement for Mitral Valve Regurgitation?

Research shows that transcatheter edge-to-edge repair (TEER) is an effective treatment for mitral regurgitation, with favorable outcomes reported over three years. Studies also compare different devices like PASCAL and MitraClip, indicating that TEER is a viable option for patients with this condition. ^{1 2 3 4 5}

How is percutaneous mitral valve repair different from other treatments for mitral valve regurgitation?

Percutaneous mitral valve repair, such as the MitraClip, is a less invasive procedure compared to traditional surgery, as it involves repairing the valve through a catheter inserted into a blood vessel rather than open-heart surgery. This approach can be particularly beneficial for patients who are at high risk for surgical complications. ^{1 2 3 6 7}

What is the purpose of this trial?

Ischemic mitral regurgitation (MR) and coronary artery disease is common and associated with significant morbidity and mortality. Ischemic MR has been traditionally treated surgically through either valve repair or replacement at the time of concomitant bypass grafting. Although patients with ischemic MR represent a heterogeneous group, outcomes for these patients over the intermediate term is poor owing to left ventricle (LV) dysfunction causing MR and the presence of coronary disease, which portends poor survival. There is an emergence of percutaneous therapies to treat MR which have been shown to be a less invasive, safe, and viable approach to treat comorbid patients. The decision to treat ischemic MR either surgically or percutaneously is influenced by the presence of coronary disease and the ability to provide adequate revascularization. Mitral valve surgery concomitant to surgical revascularization, however, is associated with a several fold increase in mortality. In fact, the incremental risk increase is further magnified in high-risk patients. We therefore propose a novel prospective study to guide intervention for ischemic MR. Patients will be randomized to undergo surgical therapy with either mitral repair/replacement and/or concomitant coronary artery bypass grafting OR percutaneous mitral repair, followed by coronary artery bypass grafting.

Research Team

Vincent Chan, MD, MPH

Principal Investigator

Ottawa Heart Institute Research Corporation

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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 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]

References

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

Three-year outcomes for transcatheter repair in patients with mitral regurgitation from the CLASP study. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Transcatheter mitral valve replacement or repair for secondary mitral regurgitation: a propensity score-matched analysis. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Characteristics and outcomes of patients undergoing transcatheter mitral valve replacement with the Tendyne system. [2023]

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

Outcomes After Transcatheter Edge-to-Edge Mitral Valve Repair According to Mitral Regurgitation Etiology and Cardiac Remodeling. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Edge-to-Edge Transcatheter Mitral Valve Repair Using PASCAL vs. MitraClip: A Systematic Review and Meta-Analysis. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

[Mitral valve: When conservative, when surgical, when interventional therapy?] [2022]

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

Operator Experience and Outcomes of Transcatheter Mitral Valve Repair in the United States. [2020]