Mitral Valve Repair Procedures for Mitral Valve Prolapse
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.12345Why 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.36789
Who Is on the Research Team?
Joanna Chikwe, MD
Principal Investigator
Cedars-Sinai
Martin Leon, MD
Principal Investigator
Columbia University
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo mitral valve repair (MVr) or transcatheter edge-to-edge repair (TEER) for degenerative mitral regurgitation
Follow-up
Participants are monitored for safety and effectiveness after treatment, including rhythm monitoring and cardiac imaging
Extension
Optional long-term follow-up to assess ongoing outcomes and treatment effects
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?
2
Treatment groups
Active Control
Patients will be treated with a commercially-approved edge-to-edge mitral repair device.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Annetine Gelijns
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Citations
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 ...
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 ...
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%.
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 ...
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, ...
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 ...
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.htmlDelaying 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 ...
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