AltaValve Pivotal Trial
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- 4C Medical Technologies, Inc.
- Study ID
- NCT06465745
- Status
- Recruiting
Conditions
- Mitral Incompetence
- Mitral Insufficiency
- Mitral Regurgitation
- Mitral Valve Incompetence
- Mitral Valve Regurgitation
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- AltaValve System. — DEVICETranscatheter Mitral Valve Replacement.
Study Details
This is a prospective, single arm, multicenter, clinical trial designed to evaluate the safety and performance of the AltaValve System for the treatment of mitral regurgitation in a targeted patient population.
Key Dates
- Start date
- Sep 3, 2024
- Status verified
- Mar 2025
- Primary completion
- Sep 30, 2029
- Completion
- Sep 30, 2031
Study Design
- Enrollment
- 450 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Primary CohortDesigned to evaluate the safety and performance of the AltaValve System for the treatment of moderate-to-severe or severe MR in a targeted patient population without at least moderate mitral annular calcification (MAC).
- Experimental: Mitral Annular Calcification Cohort (MAC)Designed to evaluate the safety and performance of the AltaValve System for the treatment of moderate-to-severe or severe MR in a targeted patient population with moderate to severe MAC.
Primary Outcome Measure
Composite of all-cause mortality or heart failure hospitalization. [ Time Frame: 12 months. ]
Locations (20)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Abrazo Arizona Heart Hospital | Phoenix | Arizona | 85016 | Principal Investigator 602-532-1000 |
| Dignity Health; St. Joseph's Hospital and Medical Center | Phoenix | Arizona | 85032 | |
| TMC Healthcare | Tucson | Arizona | 85712 | Principal Investigator 520-327-5461 |
| Sutter Bay Hospitals | San Francisco | California | 94107 | |
| Los Robles Hospital & Medical Center | Thousand Oaks | California | 91360 | |
| Cardiovascular Institute of the South | Houma | Louisiana | 70360 | |
| MedStar Health Research Institute, Inc. | Columbia | Maryland | 21044 | |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | Principal Investigator 248-551-1235 |
| Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | 55407 | |
| Mayo Clinic | Rochester | Minnesota | 55905 | Principal Investigator 800-664-4542 |
| Washington University | St Louis | Missouri | 63110 | |
| AHS Hospital Corp. | Morristown | New Jersey | 07960 | Principal Investigator 973-971-5000 |
| New York Presbyterian Hospital-Columbia University Medical Center | New York | New York | 10032 | |
| Montefiore Medical Center | The Bronx | New York | 10467 | |
| The Charlotte-Mecklenburg Hospital; Atrium Health | Charlotte | North Carolina | 28203 | |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | Principal Investigator 833-788-7425 |
| South Oklahoma Heart Research, LLC. | Oklahoma City | Oklahoma | 73135 | Principal Investigator 405-628-6000 |
| Oregon Health & Science University | Portland | Oregon | 97239 | |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | |
| University of Virginia | Charlottesville | Virginia | 22903 |
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