Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
15 participants
INTERVENTIONAL
2019-12-04
2025-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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AltaValve
Transcatheter Mitral Valve Replacement
Eligibility Criteria
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Inclusion Criteria
2. Subjects symptomatic New York Heart Association (NYHA) II-IV.
3. Subjects with severe MR as documented by echo.
4. Subjects who are at high risk for open-heart surgery as documented by the health care professional (e.g., Heart Team consisting of cardiac surgeon and interventional cardiologist in United States).
Exclusion Criteria
2. Unwilling or unable to sign the Informed Consent Form (ICF).
3. History of any cognitive or mental health status that would interfere with study participation.
4. Currently enrolled in any other pre-approval investigational study (does not apply to long-term post-market studies unless these studies might clinically interfere with the current study endpoints (e.g., limit use of study-required medication, etc.)).
5. Female subjects who are pregnant or planning to become pregnant within the study period.
6. Known hypersensitivity or contraindication to aspirin, heparin, or Warfarin without adequate alternative medications.
7. Known hypersensitivity to nitinol (i.e., nickel allergy) that cannot be adequately medicated.
8. Known hypersensitivity to contrast media that cannot be adequately medicated.
9. Evidence of current Left Ventricular Ejection Fraction (LVEF) ≤30% (where current is defined as the latest LVEF measurement completed within 90 days prior to the index procedure).
10. Concurrent medical condition with a life expectancy of less than 12 months.
11. Prior mitral valve repair/replacement (excluding prior surgical mitral valve repair, annuloplasty, or MitraClip not interfering with AltaValve placement).
18 Years
ALL
No
Sponsors
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4C Medical Technologies, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Philippe Genereux, MD
Role: PRINCIPAL_INVESTIGATOR
Morristown Medical Center
Vinayak Bapat, MD
Role: PRINCIPAL_INVESTIGATOR
Allina Health System
Locations
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Tucson Medical Center
Tucson, Arizona, United States
Los Robles Regional Medical Center
Thousand Oaks, California, United States
MedStar Washington Hospital
Washington D.C., District of Columbia, United States
Tampa General Hospital
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Cardiovascular Institute of the South
Houma, Louisiana, United States
Morristown Medical Center
Morristown, New Jersey, United States
Atrium Health
Charlotte, North Carolina, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States
Baptist Memorial Hospital - Memphis
Memphis, Tennessee, United States
Houston Methodist Hospital
Houston, Texas, United States
Baylor Scott & White
Plano, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1890
Identifier Type: -
Identifier Source: org_study_id
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