TMVR for Mitral Valve Disease
(INTERLUDE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to assess the safety and performance of Transcatheter Mitral Valve Replacement (TMVR) system for the treatment of severe, symptomatic mitral regurgitation (MR).
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.
Is transcatheter mitral valve replacement (TMVR) generally safe for humans?
How is the treatment TMVR for Mitral Valve Disease different from other treatments?
Transcatheter Mitral Valve Replacement (TMVR) is a new treatment option for severe mitral valve issues, especially for patients who are not good candidates for traditional surgery. Unlike conventional surgery, TMVR is performed using a catheter (a thin tube) to replace the valve, which can be less invasive and is currently being tested for its effectiveness and safety.678910
What data supports the effectiveness of the treatment Transcatheter Mitral Valve Replacement (TMVR) for Mitral Valve Disease?
TMVR is a new treatment option for severe mitral regurgitation (a condition where the heart's mitral valve doesn't close tightly), and early experiences show it can be done successfully, although the number of cases is still small. It has been used for patients who can't have surgery, and while it shows promise, more studies are needed to confirm its safety and effectiveness.68111213
Who Is on the Research Team?
Mat Williams, M.D.
Principal Investigator
NYU Langone Medical Center
Are You a Good Fit for This Trial?
This trial is for individuals at high risk for heart surgery with severe, symptomatic mitral regurgitation and classified as NYHA Class II-IVa. It's not suitable for those with excessive calcification of the mitral valve, severe right ventricular dysfunction, recent stroke or heart attack, or certain other heart conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients with symptomatic mitral regurgitation are treated with the Caisson Transcatheter Mitral Valve Replacement (TMVR) System
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Transcatheter Mitral Valve Replacement
Find a Clinic Near You
Who Is Running the Clinical Trial?
Caisson Interventional LLC
Lead Sponsor