Innovalve mitral valve replacement system evaluation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and performance of the Innovalve mitral valve replacement system in patients with significant mitral valve regurgitation. It is a multi-center, First-In-Human, prospective, single-arm early feasibility study. The trial aims to determine how well the device functions and its safety profile in a high-risk patient population. Participants will be monitored for outcomes related to the device's performance and any adverse events.

Why it matters

Who can join: the full rules

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%

Where it's running

• Cedars-Sinai
  Los Angeles, California, United States Recruiting
• Stanford University
  Palo Alto, California, United States Recruiting
• Naples Comprehensive Health
  Naples, Florida, United States Recruiting
• Emory University
  Atlanta, Georgia, United States Recruiting
• Piedmont Heart Institute
  Atlanta, Georgia, United States Recruiting
• Northwestern
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Chet Rihal — Mayo Clinic
• Study coordinator: TMTT Clinical
• Email: TMTT_Clinical@edwards.com
• Phone: (949) 250-2500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.