EFS of the CardioMech MVRS
Part of paid clinical trials in Thousand Oaks, California.
- Sponsor
- CardioMech AS
- Study ID
- NCT04820764
- Status
- Recruiting
Conditions
- Mitral Regurgitation
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- CardioMech MVRS — DEVICECardioMech MVRS
Study Details
Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.
Key Dates
- Start date
- Jul 27, 2021
- Status verified
- Jan 2026
- Primary completion
- Sep 30, 2026
- Completion
- Sep 30, 2031
Study Design
- Enrollment
- 25 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DEVICE_FEASIBILITY
Arms
- Experimental: CardioMech Mitral Valve Repair System (MVRS)
Primary Outcome Measure
Freedom from serious adverse events determined to be related to the CardioMech MVRS device or procedure [ Time Frame: 30 days ]
Central Contacts
- Jennifer Ruether651-248-4440
- Rick Nehm
Locations (12)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cardiovascular Institute of Los Robles Health System | Thousand Oaks | California | 91360 | - |
| Northwestern University | Evanston | Illinois | 60208 | Justin Cortez Charles Davidson, MD (PRINCIPAL_INVESTIGATOR) |
| Ascension St. Francis via Christi | Wichita | Kansas | 67226 | Meredith Thunberg, RN, BSN Bassem Chehab, MD (PRINCIPAL_INVESTIGATOR) Brett Grizzell, MD (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic | Rochester | Minnesota | 55902 | Anna Reed Mayra Guerrero, MD (PRINCIPAL_INVESTIGATOR) |
| CentraCare Heart & Vascular Center | Saint Cloud | Minnesota | 56303 | Jennifer Humbert Thom Dahle, MD (PRINCIPAL_INVESTIGATOR) |
| NYU Langone | New York | New York | 10016 | Patricia Kozikowski Mathew Williams, MD (PRINCIPAL_INVESTIGATOR) |
| Atrium Health Sanger Heart and Vascular Institute | Charlotte | North Carolina | 28204 | - |
| The Christ Hospital | Cincinnati | Ohio | 45219 | Jamie Bley Santiago Garcia, MD (PRINCIPAL_INVESTIGATOR) |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Shawn McDaniel Samir Kapadia, MD (PRINCIPAL_INVESTIGATOR) |
| Ascension St. Thomas West | Nashville | Tennessee | 37205 | Emily Normandin Evelio Rodriguez, MD (PRINCIPAL_INVESTIGATOR) Andrew Morse, MD (PRINCIPAL_INVESTIGATOR) |
| Baylor Scott & White, The Heart Hospital | Plano | Texas | 75093 | Jasmine Kennedy Robert Smith, MD (PRINCIPAL_INVESTIGATOR) |
| Intermountain Medical Center | Murray | Utah | 84107 | Lexi Maycock Brian Whisenant, MD (PRINCIPAL_INVESTIGATOR) |
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