AltaValve Pivotal Trial
- Conditions
- Mitral IncompetenceMitral Valve IncompetenceMitral RegurgitationMitral InsufficiencyMitral Valve Regurgitation
- Interventions
- Device: AltaValve System.
- Registration Number
- NCT06465745
- Lead Sponsor
- 4C Medical Technologies, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 450
- Age ≥ 18 years.
- Symptomatic New York Heart Association (NYHA) class II-IV.
- Moderate-to-severe or severe MR (3+) despite optimal guideline-directed medical therapy (GDMT) as determined by an independent Echo Core Lab.
- Unsuitable for surgery and Transcatheter Edge-toEdge Repair (TEER) as determined by the local site Heart Team.
Exclusion Criteria (Abbreviated List):
- Inability to understand the trial or a history of non-compliance with medical advice.
- Inability to provide signed Informed Consent Form (ICF).
- History of any cognitive or mental health status that would interfere with participation in the trial.
- Currently enrolled in any other pre-approval investigational trial (does not apply to long-term post-market trials unless these trials might clinically interfere with the current trial endpoints (e.g., limit use of trial-required medication, etc.)).
- Female subjects who are pregnant or planning to become pregnant within the trial period.
- Known hypersensitivity or contraindication to heparin, or warfarin without adequate alternative medications.
- Known hypersensitivity to nitinol (i.e., nickel allergy) that cannot be adequately medicated.
- Known hypersensitivity to contrast media that cannot be adequately medicated.
- Evidence of current left ventricular ejection fraction (LVEF) ≤ 25%.
- Concurrent medical condition with a life expectancy of less than 12 months.
- Transcatheter aortic repair or replacement within 90 days prior to the index procedure.
- Percutaneous coronary intervention (PCI) within 90 days prior to the index procedure.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Mitral Annular Calcification Cohort (MAC) AltaValve System. 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 Cohort AltaValve System. 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 without at least moderate mitral annular calcification (MAC).
- Primary Outcome Measures
Name Time Method Composite of all-cause mortality or heart failure hospitalization. 12 months.
- Secondary Outcome Measures
Name Time Method Changes in Kansas City Cardiomyopathy Questionnaire (KCCQ). 6 months and 1 year. Quality of life improvement.
All-cause mortality, disabling stroke, acute kidney injury (stage 3 or with renal replacement), mitral valve re-intervention (surgical or transcatheter), major bleeding requiring intervention. 30 Days or hospital discharge (whichever is longer). Composite.
Technical success. Day 0. Technical success will be considered achieve when all of the following are present:
* Successful application of the delivery system as intended.
* Successful device placement.
* Reduction in mitral regurgitation grade to ≤ 2+.Mitral valve re-intervention. At 30 days, 6 months, 1 year, and annually thereafter for up to 5 years. Mitral valve re-intervention after index procedure
Changes in Six-minute walk test (6MWT). 6 months and 1 year. Quality of life improvement.
New pacemaker rate. 1 month, 6 months and 1 year.
Trial Locations
- Locations (29)
Abrazo Arizona Heart Hospital
🇺🇸Phoenix, Arizona, United States
Dignity Health; St. Joseph's Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
TMC Healthcare
🇺🇸Tucson, Arizona, United States
Sutter Bay Hospitals
🇺🇸San Francisco, California, United States
Los Robles Hospital & Medical Center
🇺🇸Thousand Oaks, California, United States
Cardiovascular Institute of the South
🇺🇸Houma, Louisiana, United States
MedStar Health Research Institute, Inc.
🇺🇸Columbia, Maryland, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
AHS Hospital Corp.
🇺🇸Morristown, New Jersey, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
New York Presbyterian Hospital-Columbia University Medical Center
🇺🇸New York, New York, United States
The Charlotte-Mecklenburg Hospital; Atrium Health
🇺🇸Charlotte, North Carolina, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
South Oklahoma Heart Research, LLC.
🇺🇸Oklahoma City, Oklahoma, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Universitatsklinikum Bonn
🇩🇪Bonn, Germany
University Hospital Cologne - Heart Center
🇩🇪Cologne, Germany
Cardiac Research GmbH; St.-Johannes-Hospital Dortmund
🇩🇪Dortmund, Germany
Heart Center Trier
🇩🇪Trier, Germany
Onassis Cardiac Surgery Center
🇬🇷Athens, Greece
Interbalkan Medical Center of Thessaloniki
🇬🇷Thessaloniki, Greece
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Fundación para la investigación biomédica del hospital clínico San Carlos
🇪🇸Madrid, Spain
Hospital Álvaro Cunqueiro
🇪🇸Vigo, Spain