Mitral Valve Repair Procedures for Mitral Valve Prolapse

Recruiting at 24 trial locations

Overseen By Chari Ponder, RN, BSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Annetine Gelijns

Disqualifiers: Severe claustrophobia, Gadolinium allergy, Defibrillator, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12-18 months

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to address mitral valve problems in the heart, which can lead to serious issues like heart failure or irregular heartbeats. The trial compares traditional mitral valve repair surgery with a less invasive procedure called transcatheter edge-to-edge repair. Participants will help researchers understand how these treatments affect heart muscle function and potentially prevent future heart problems. Individuals diagnosed with mitral valve prolapse and already part of a related study might be suitable for this trial. As an unphased trial, this study offers participants the chance to contribute to vital research that could enhance future treatment options for mitral valve issues.

Will I have to stop taking my current medications?

The trial information 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 prior data suggests that these mitral valve repair procedures are safe?

Research has shown that both mitral valve repair and transcatheter edge-to-edge repair (TEER) are generally safe procedures.

For TEER, studies have found it to be safe, with many patients experiencing good outcomes. One year after the procedure, patients had fewer hospital visits for heart failure and a lower risk of death. Serious issues, such as parts of the valve not attaching properly, occurred in only 1% of cases, and major bleeding happened in just 2.4% of patients.

Similarly, mitral valve repair surgery is considered safe. Research indicates that the risk of death from the surgery is less than 1% for most patients. This procedure also provides long-term benefits, such as better survival rates and improved heart function. Reports show a low risk of death during surgery and shorter hospital stays.

In summary, both treatment options have strong safety evidence, making them good choices for those considering joining a clinical trial for mitral valve prolapse. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mitral valve repair procedures being studied because they offer innovative approaches to treating mitral valve prolapse, a condition commonly managed with traditional surgical repair or replacement. The transcatheter edge-to-edge repair is unique because it uses a minimally invasive device to clip the leaflets of the mitral valve together, which can potentially reduce recovery time and be a less risky option for patients who are not ideal candidates for open-heart surgery. On the other hand, the mitral valve repair through surgery provides the flexibility to be performed with robotic assistance, which may enhance precision and outcomes. These options could expand the toolkit for doctors, offering more tailored solutions based on patient needs.

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

This trial will compare two treatments for mitral valve prolapse: mitral valve repair surgery and transcatheter edge-to-edge repair (TEER). Research has shown that mitral valve repair surgery is highly successful, with almost all patients achieving a successful repair. In the long term, about 95% of patients do not require another surgery for at least eight years. TEER also shows promising results, with over 90% of patients experiencing significant improvement in valve function within a year. Additionally, TEER is associated with fewer hospital visits for heart failure and a lower risk of death. Both treatments are safe and effective, providing reliable options for managing mitral valve prolapse. ^{3 6 7 8 9}

Who Is on the Research Team?

Martin Leon, MD

Principal Investigator

Columbia University

Joanna Chikwe, MD

Principal Investigator

Cedars-Sinai

Are You a Good Fit for This Trial?

The PRIMARY Ancillary Substudy is for individuals with mitral valve prolapse (MVP) who may also have cardiomyopathy or ventricular arrhythmias. Participants are likely involved in the main PRIMARY trial comparing mitral valve repair to transcatheter-edge-to-edge-repair.

Inclusion Criteria

Patients who meet all eligibility criteria and are randomized in the parent PRIMARY trial

For the ancillary biospecimen study, patients who are randomized to MVr in the parent trial.

Exclusion Criteria

Known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies (for patients undergoing rhythm monitoring)

Severe claustrophobia not controlled with sedation

Prior adverse reaction to gadolinium administration

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo mitral valve repair (MVr) or transcatheter edge-to-edge repair (TEER) for degenerative mitral regurgitation

12-18 months

Multiple visits for intervention and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including rhythm monitoring and cardiac imaging

12 months

Regular follow-up visits for imaging and monitoring

Extension

Optional long-term follow-up to assess ongoing outcomes and treatment effects

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Cardiac Magnetic Resonance Imaging
• Myocardial Tissue Biopsy

Trial Overview This substudy uses Cardiac Magnetic Resonance Imaging, ZioPatch Monitoring, and Myocardial Tissue Biopsy to understand how MVP affects heart muscle structure/function and its link to arrhythmias/sudden death. It aims to improve treatment strategies for different patient groups.

How Is the Trial Designed?

Group I: Transcatheter edge-to-edge repair Active Control 2 Interventions

Patients will be treated with a commercially-approved edge-to-edge mitral repair device.

Group II: Mitral valve repair Active Control 3 Interventions

Mitral surgery will be conducted using general anesthesia and cardiopulmonary bypass. Mitral surgery may be performed via a sternotomy or a right thoracotomy approach with or without robotic assistance.

Who Is Running the Clinical Trial?

Annetine Gelijns

Lead Sponsor

Trials

3

Recruited

870+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5873787/

Long-Term Results of Mitral Valve Repair - PMC Freedom from mitral valve failure was 84.5% at 10 years, with no difference between degenerative and rheumatic valves. Overall, late ≥ moderate tricuspid ...

2. cedars-sinai.org cedars-sinai.org/newsroom/study-transcatheter-mitral-valve-repair-safe-successful/

Study: Transcatheter Mitral Valve Repair Safe, Successful A minimally invasive procedure for leaky heart valves was found to be safe and effective in nearly 90% of patients, according to research by ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S002252231200013X

A near 100% repair rate for mitral valve prolapse is ... There was 1 early valve replacement (99.9% repair rate) due to atrioventricular groove bleeding and 5 late re-repairs (0.7%) due to disease progression or ...

4. annalscts.com annalscts.com/article/view/16967/html

Systematic review and meta-analysis of mid-term survival, ... The results from this present meta-analysis showed that at eight-years post-RMVr the rate of freedom from mitral valve reoperation was estimated to be 95.0%.

5. acc.org acc.org/Latest-in-Cardiology/Articles/2023/09/01/01/42/cover-story-exploring-the-impact-of-transcatheter-mitral-valve-repair-real-world-outcomes

Exploring the Impact of Transcatheter Mitral Valve Repair: ... This real-world analysis found that overall mortality after mitral valve repair was very low at 1.16%. Mortality was higher in patients for whom ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4356723/

Long-term Outcomes of Mitral Valve Repair Versus ... These advantages include lower operative mortality, improved survival, better preservation of left-ventricular function, shorter post-operative hospital stay, ...

7. jacc.org jacc.org/doi/10.1016/j.jacc.2022.11.017

Risk of Surgical Mitral Valve Repair for Primary ... - JACC This etiologic and procedure-specific risk model establishes that the contemporary mortality risk of MV repair for primary MR is <1% for the vast majority of ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0167527325002189

Outcomes of mitral valve reoperation and first-time surgery ... Our study found that 180-day mortality was 7.1 % following first-time surgery for mitral regurgitation and 10.1 % following mitral reoperation.

9. medschool.umaryland.edu medschool.umaryland.edu/news/2018/Delaying-Mitral-Valve-Surgery-May-Harm-Patients.html

Delaying Mitral Valve Surgery May Harm Patients A new study has found that a pioneering device to repair heart valves is safe and effective, and can reduce the invasiveness and side effects of ...