AltaValve Early Feasibility Study Protocol (NCT03997305) | Clinical Trial Compass
UnknownNot Applicable
AltaValve Early Feasibility Study Protocol
United States15 participantsStarted 2019-12-04
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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).
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.