TVMR With the INNOVALVE System Trial - Early Feasibility Study
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Edwards Lifesciences
- Study ID
- NCT04919980
- Status
- Recruiting
Conditions
- Mitral Valve Regurgitation (Degenerative or Functional)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- INNOVALVE system — DEVICEINNOVALVE system
Study Details
Study to evaluate the safety and performance of the INNOVALVE system
Key Dates
- Start date
- Sep 1, 2022
- Status verified
- Apr 2026
- Primary completion
- Jul 1, 2026
- Completion
- Jul 1, 2031
Study Design
- Enrollment
- 65 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: TreatmentMV replacement with INNOVALVE system
Primary Outcome Measure
Absence of implant or delivery related serious adverse events at 30 Days [ Time Frame: 30 days ]
Central Contacts
- TMTT Clinical(949) 250-2500
Locations (20)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cedars-Sinai | Los Angeles | California | 90048 | Rajendra Makkar, MD (PRINCIPAL_INVESTIGATOR) |
| Stanford University | Palo Alto | California | 94305 | Alan Yeung, MD (PRINCIPAL_INVESTIGATOR) |
| Naples Comprehensive Health | Naples | Florida | 34102 | Robert Cubeddu, MD (PRINCIPAL_INVESTIGATOR) |
| Emory University | Atlanta | Georgia | 30308 | Adam Greenbaum, MD (PRINCIPAL_INVESTIGATOR) |
| Piedmont Heart Institute | Atlanta | Georgia | 30309 | Vinod Thourani, MD (PRINCIPAL_INVESTIGATOR) |
| Northwestern | Chicago | Illinois | 60611 | Charles Davidson, MD (PRINCIPAL_INVESTIGATOR) |
| University of Michigan Hospital and Health Systems | Ann Arbor | Michigan | 48109 | Stanley Chetcuti, MD (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic | Rochester | Minnesota | 555905 | Carl Griffin Mackram Eleid, MD (PRINCIPAL_INVESTIGATOR) |
| Saint Luke's Hospital | Kansas City | Missouri | 64111 | Adnan Chhatriwalla, MD (PRINCIPAL_INVESTIGATOR) |
| Morristown Medical Center | Morristown | New Jersey | 07960 | Gennaro Giustino, MD (PRINCIPAL_INVESTIGATOR) |
| Northwell Health | Manhasset | New York | 11030 | Bruce Rutkin, MD (PRINCIPAL_INVESTIGATOR) |
| Cornell | New York | New York | 10021 | - |
| NewYork-Presbyterian / Columbia University | New York | New York | 10032 | Treena Williams Susheel Kodali, MD (PRINCIPAL_INVESTIGATOR) |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Samir Kapadia, MD (PRINCIPAL_INVESTIGATOR) |
| OhioHealth Research Institute | Columbus | Ohio | 43214 | Carlos Sanchez, MD (PRINCIPAL_INVESTIGATOR) Steven Yakubov, MD (SUB_INVESTIGATOR) |
| Oregon Health & Science Universtiy | Portland | Oregon | 97239 | Firas Zahr, MD (PRINCIPAL_INVESTIGATOR) |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | Paul Fiorilli, MD (PRINCIPAL_INVESTIGATOR) |
| Ascension Saint Thomas | Nashville | Tennessee | 37205 | Andrew Morse, MD (PRINCIPAL_INVESTIGATOR) |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37203 | Colin M Barker, MD (PRINCIPAL_INVESTIGATOR) |
| Swedish Medical Center | Seattle | Washington | 98122 | Sidakpal Panaich, MD (PRINCIPAL_INVESTIGATOR) |