AltaValve Early Feasibility Study Protocol

  • STATUS
    Recruiting
  • End date
    Sep 17, 2025
  • participants needed
    15
  • sponsor
    4C Medical Technologies, Inc.
Updated on 17 June 2022
Investigator
Jennifer Humbert, BSN
Primary Contact
CentraCare Hearth and Vascular Center (1.7 mi away) Contact
+10 other location
regurgitation
heart surgery
mitral valve replacement

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.

Details
Condition Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Incompetence, Mitral Valve Regurgitation, Mitral Incompetence
Treatment AltaValve
Clinical Study IdentifierNCT03997305
Sponsor4C Medical Technologies, Inc.
Last Modified on17 June 2022

Eligibility

Yes No Not Sure

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
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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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