Early Feasibility Study of the INNOVALVE System for Mitral Valve Regurgitation
This study is testing a new device called the INNOVALVE system for people with mitral valve regurgitation (a condition where the heart's mitral valve doesn't close properly, causing blood to leak backward). You might be able to join if you have significant symptoms from this condition, are considered high-risk for open-heart surgery, and meet specific anatomical requirements. The main goal of this study is to see if the INNOVALVE system can be safely implanted without serious problems within 30 days. This is an early study, and the current recruitment status is unclear, with a plan to enroll about 65 participants.
- Study design
- This is a First-In-Human, multi-center, prospective, single-arm study designed to evaluate the safety and performance of the INNOVALVE system. It plans to enroll about 65 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary safety endpoint is measured at 30 days after the implant or delivery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
TVMR With the INNOVALVE System Trial - Early Feasibility Study
At a glance
Conditions
Where it's being run
20 sites across 14 statesStudy leadership
- Chet Rihal · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Absence of implant or delivery related serious adverse events at 30 Days30 days
Absence of implant or delivery related serious adverse events