AltaValve Early Feasibility Study Protocol
Status unconfirmed · Not applicable
Conditions studied: Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Incompetence, Mitral Valve Regurgitation, Mitral Incompetence
In brief
Prospective, single-arm, multicenter study to evaluate the safety and performance of the AltaValve for the treatment of moderate to severe or severe mitral valve regurgitation in subjects who are considered high risk for mortality and morbidity from conventional open-heart surgery.
Key facts
- Study ID
- NCT03997305
- Run by
- 4C Medical Technologies, Inc.
- People needed
- 15
- Starts
- 2019-12-04
- Expected to finish
- 2025-09-01
- Last updated by the study team
- 2023-09-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects ≥ 18 years of age.
- Subjects symptomatic New York Heart Association (NYHA) II-IV.
- Subjects with severe MR as documented by echo.
- 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).
- Abbreviated Exclusion Criteria:
- Inability to understand the study or a history of non-compliance with medical advice.
- Unwilling or unable to sign the Informed Consent Form (ICF).
- History of any cognitive or mental health status that would interfere with study participation.
- 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.)).
- Female subjects who are pregnant or planning to become pregnant within the study period.
- Known hypersensitivity or contraindication to aspirin, 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) ≤30% (where current is defined as the latest LVEF measurement completed within 90 days prior to the index procedure).
- Concurrent medical condition with a life expectancy of less than 12 months.
- Prior mitral valve repair/replacement (excluding prior surgical mitral valve repair, annuloplasty, or MitraClip not interfering with AltaValve placement).
Where it is running
- Tucson Medical Center — Tucson, Arizona, United States (enrolling)
- Los Robles Regional Medical Center — Thousand Oaks, California, United States (enrolling)
- MedStar Washington Hospital — Washington D.C., District of Columbia, United States (enrolling)
- Tampa General Hospital — Tampa, Florida, United States (enrolling)
- Emory University — Atlanta, Georgia, United States (enrolling)
- Cardiovascular Institute of the South — Houma, Louisiana, United States (enrolling)
- Morristown Medical Center — Morristown, New Jersey, United States (enrolling)
- Atrium Health — Charlotte, North Carolina, United States (enrolling)
- Oklahoma Heart Hospital — Oklahoma City, Oklahoma, United States (enrolling)
- Baptist Memorial Hospital - Memphis — Memphis, Tennessee, United States (enrolling)
- Houston Methodist Hospital — Houston, Texas, United States (enrolling)
- Baylor Scott & White — Plano, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.