RecruitingMitral RegurgitationMitral InsufficiencyMitral Valve Incompetence

AltaValve Pivotal Trial

Eligible age

18+ yrs

Accepts

All genders

Locations

15 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

Check my eligibility →

About this study

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.

Sponsor: 4C Medical Technologies, Inc.

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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.