TVMR With the INNOVALVE System Trial - Early | Clinical Research Studies Listing

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Recruiting

18 years or above

All

Phase N/A

65 participants needed

1 Location

Brief description of study

Study to evaluate the safety and performance of the INNOVALVE system

Detailed description of study

The study is a multi-center, First-In-Human, prospective, single arm early feasibility study to evaluate the safety and performance of the INNOVALVE system

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions: Mitral Valve Regurgitation (Degenerative or Functional)
Age: 18 years or above
Gender: All

Inclusion Criteria:

Clinically significant, symptomatic mitral regurgitation
High risk for open-heart surgery
Meets anatomical criteria

Exclusion Criteria:

Unsuitable anatomy
Patient is inoperable
EF<25%

This study investigates the safety and performance of an investigational heart valve system in patients with clinically significant, symptomatic mitral regurgitation. Participants in this study will undergo procedures to implant the investigational heart valve system. The study will closely monitor participants for any side effects or complications related to the procedure and device. This is a single arm study, meaning all participants will receive the investigational heart valve system.

Who can participate: Adults with specific heart valve issues and high surgery risk can join. Those with certain heart conditions or anatomy that doesn't fit are excluded.
Study details: Participants will get a heart valve system and be checked for safety and how well it works.

Updated on 28 May 2026. Study ID: 23-0150

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