Transcatheter Mitral Valve Repair for Mitral Valve Prolapse
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new device called the Vesalius TMVr System, a transcatheter mitral valve repair device, to determine its safety and effectiveness for people with degenerative mitral regurgitation. This condition causes blood to leak backward in the heart, leading to symptoms like shortness of breath and fatigue. The trial seeks participants with moderate to severe mitral valve issues who cannot undergo regular surgery due to high risk. Participants will receive the device implant and undergo monitoring to assess its effectiveness and any side effects. As an unphased trial, this study offers a chance to contribute to groundbreaking research that could lead to new treatment options for those unable to undergo traditional surgery.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you have a contraindication (reason not to use) to anticoagulation or antiplatelet therapy, you cannot participate in the trial.
What prior data suggests that the Vesalius TMVr System is safe for patients with degenerative mitral regurgitation?
Research has shown that the Vesalius Transcatheter Mitral Valve Repair (TMVr) System is under evaluation for safety and effectiveness in treating degenerative mitral regurgitation. In a small study with 50 patients, the treatment succeeded in 98% of cases. However, 14% of patients died within the first 30 days, indicating serious risks.
Another study found the TMVr procedure was technically successful in 97.5% of cases. After 30 days, 2.5% of patients developed blood clots in the heart valve, and one patient died from a stroke.
These findings suggest that while the treatment often achieves its immediate goals, significant risks remain. Potential participants should discuss these risks with their doctors and consider their own health conditions before deciding to join the trial.12345Why are researchers excited about this trial?
The Vesalius TMVr System is unique because it offers a minimally invasive approach to repairing the mitral valve, which is quite different from the traditional open-heart surgery. Most treatments for mitral valve prolapse involve surgical repair or replacement, requiring significant recovery time. However, the Vesalius system is delivered via a catheter, allowing the procedure to be performed without opening the chest and potentially reducing recovery time and associated risks. Researchers are excited about this treatment because it targets the mitral valve more directly and efficiently, which could improve patient outcomes and make the procedure accessible to those who are not candidates for surgery.
What evidence suggests that the Vesalius TMVr System is effective for mitral valve prolapse?
Research has shown that transcatheter mitral valve repair (TMVR) effectively treats mitral regurgitation, particularly in high-risk patients. Studies have found that TMVR significantly improves quality of life and offers good survival rates. One study found that patients who underwent TMVR spent less time in the hospital compared to those who had traditional surgery. Another study reported a high success rate in valve placement, with many patients experiencing no remaining mitral regurgitation. The procedure generally leads to good results and symptom reduction. Participants in this trial will receive the Vesalius TMVr System, which will be evaluated for safety, device performance, and clinical outcomes.15678
Are You a Good Fit for This Trial?
This trial is for adults (19+) with moderate to severe degenerative mitral valve regurgitation who have symptoms and are at high risk for traditional heart surgery. Participants must be able to give consent, have suitable heart anatomy, and agree to long-term follow-up.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo implantation with the Vesalius Transcatheter Mitral Valve Repair (TMVr) System
Follow-up
Participants are monitored for safety, device performance, and clinical outcomes at predefined intervals
What Are the Treatments Tested in This Trial?
Interventions
- Vesalius TMVr System
Trial Overview
The study tests the safety and effectiveness of the Vesalius Transcatheter Mitral Valve Repair (TMVr) System—a minimally invasive device implanted in the heart—specifically in people unable to undergo standard surgical repair.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants in this arm will undergo implantation with the Vesalius Transcatheter Mitral Valve Repair (TMVr) System according to the study protocol. All procedures will be performed by trained interventional cardiologists, and participants will be followed for safety, device performance, and clinical outcomes at predefined intervals.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vesalius Cardiovascular Inc.
Lead Sponsor
Citations
Outcomes of open mitral valve replacement versus ... - PMC
Patients undergoing TMVR were older and more financially affluent. TMVR was more costly but was associated with a shorter hospital stay and similar mortality ...
Long-Term Clinical and Hemodynamic Outcomes of ...
A total of 200 patients underwent TMVR: 60.5% (121 of 200) valve-in-valve, 22.5% (45 of 200) valve-in-ring, and 17% (34 of 200) valve–in–mitral ...
Contemporary Outcomes and Trends for the Transseptal ...
This multicenter, prospective study reports excellent procedural outcomes, acceptable 1-year mortality rates, and a significant improvement in quality of life
4.
eurointervention.pcronline.com
eurointervention.pcronline.com/article/clinical-outcomes-of-transcatheter-mitral-valve-replacement-two-year-results-of-the-choice-mi-registryClinical outcomes of transcatheter mitral valve replacement
This study aimed to assess the 2-year outcomes and predictors of mortality in patients undergoing TMVR from the multicentre CHOICE-MI Registry.
Comparative midterm results of surgical mitral valve ...
Compared with surgical MVR, TMVR demonstrated its effectiveness in high-risk patients, with shorter hospitalization time, acceptable survival, and improvement ...
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 ...
7.
ctv.veeva.com
ctv.veeva.com/study/fih-ita-study-vesalius-tmvr-system-for-symptomatic-degenerative-mitral-regurgitationVesalius TMVr System for Symptomatic Degenerative Mitral ...
This first-in-human study evaluates the safety and performance of the Vesalius Transcatheter Mitral Valve Repair (TMVr) System in patients ...
8.
frontiersin.org
frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2026.1747077/fullThe outcomes of valve-in-valve TMVR for patients with ...
The success rate of the TMVR was 100.0%. One patient had a complication of cerebral infarction and eventually died 7 days after the operation. Compared with ...
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