Transcatheter Mitral Valve Replacement for Mitral Valve Regurgitation
Trial Summary
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 data supports the effectiveness of the treatment Twelve TMVR Implant for mitral valve regurgitation?
The treatment, known as transcatheter mitral valve replacement (TMVR), has shown potential in treating severe mitral regurgitation, with some early studies indicating feasibility and successful use in patients with other valve issues. However, the experience is limited, and there are high risks involved, suggesting the need for further research and improvements.12345
Is transcatheter mitral valve replacement (TMVR) generally safe for humans?
How is the Twelve TMVR Implant treatment different from other treatments for mitral valve regurgitation?
The Twelve TMVR Implant is a unique treatment for mitral valve regurgitation because it is a transcatheter mitral valve replacement (TMVR) that offers a less invasive alternative to open-heart surgery, using either transseptal or transapical routes to deliver the device. This approach is particularly beneficial for high-risk patients who may not be suitable candidates for traditional surgery.123511
What is the purpose of this trial?
This trial tests new devices that replace a leaky heart valve without major surgery. It targets high-risk patients who can't undergo traditional surgery. The devices are inserted through a small tube to fix the valve.
Research Team
Lynnett Stahl
Principal Investigator
Medtronic
Eligibility Criteria
This trial is for very high-risk patients with severe, symptomatic mitral valve regurgitation (MR Grade 3-4+), specifically those who can undergo a transcatheter procedure. Participants must have a heart structure that fits the TMVR system and not have had recent strokes, heart attacks, or other valve surgeries.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Transcatheter Mitral Valve Replacement (TMVR) implant
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Twelve TMVR Implant
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medtronic Cardiovascular
Lead Sponsor
Geoff Martha
Medtronic Cardiovascular
Chief Executive Officer since 2020
Finance degree from Penn State University
Dr. Kendra J. Grubb
Medtronic Cardiovascular
Chief Medical Officer
MD from Emory University
Medtronic
Industry Sponsor
Geoff Martha
Medtronic
Chief Executive Officer since 2020
Finance degree from Penn State University
Dr. Richard Kuntz
Medtronic
Chief Medical Officer since 2023
MD, MSc