Innovalve mitral valve replacement system evaluation
TVMR With the INNOVALVE System Trial - Early Feasibility Study
This study is testing a new mitral valve replacement system to see if it is safe and works well for patients with severe mitral valve leakage.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 65 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Edwards Lifesciences Industry-sponsored |
| Locations | 17 sites (Los Angeles, California and 16 other locations) |
| Trial ID | NCT04919980 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with clinically significant, symptomatic mitral regurgitation who are considered high risk for open-heart surgery.
Not a fit: Patients with unsuitable anatomy, those who are inoperable, or those with an ejection fraction less than 25% may not benefit from this study.
Why it matters
Potential benefit: If successful, this could provide a less invasive treatment option for patients with significant mitral valve regurgitation who are at high risk for traditional surgery.
How similar studies have performed: While this approach is novel, similar studies evaluating innovative mitral valve replacement systems have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Los Angeles, California and 16 other locations
- Cedars-Sinai — Los Angeles, California, United States (Recruiting)
- Naples Comprehensive Health — Naples, Florida, United States (Recruiting)
- Piedmont Heart Institute — Atlanta, Georgia, United States (Recruiting)
- Northwestern — Chicago, Illinois, United States (Recruiting)
- University of Michigan Hospital and Health Systems — Ann Arbor, Michigan, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- Morristown Medical Center — Morristown, New Jersey, United States (Recruiting)
- Northwell Health — Manhasset, New York, United States (Recruiting)
- Cornell — New York, New York, United States (Withdrawn)
- NewYork-Presbyterian / Columbia University — New York, New York, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- OhioHealth Research Institute — Columbus, Ohio, United States (Recruiting)
- Oregon Health & Science Universtiy — Portland, Oregon, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
- Ascension Saint Thomas — Nashville, Tennessee, United States (Recruiting)
- Swedish Medical Center — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Chet Rihal — Mayo Clinic
- Study coordinator: TMTT Clinical
- Email: TMTT_Clinical@edwards.com
- Phone: (949) 250-2500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.