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Evaluation of the AltaValve System for treating mitral regurgitation

AltaValve Pivotal Trial

NA · 4C Medical Technologies, Inc. · NCT06465745

This study is testing a new device called the AltaValve System to see if it can help people with mitral regurgitation who can't have surgery feel better and improve their heart function.

Quick facts

PhaseNA
Study typeInterventional
Enrollment450 (estimated)
Ages18 Years and up
SexAll
Sponsor4C Medical Technologies, Inc. (industry)
Locations29 sites (Phoenix, Arizona and 28 other locations)
Trial IDNCT06465745 on ClinicalTrials.gov

What this trial studies

This clinical trial is designed to assess the safety and performance of the AltaValve System in patients suffering from symptomatic mitral regurgitation. It is a prospective, single-arm, multicenter trial that targets individuals who are not suitable for surgical intervention or other repair methods. Participants will be monitored for their response to the treatment, which aims to alleviate symptoms and improve heart function. The study will involve multiple healthcare centers to gather a diverse patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with symptomatic moderate-to-severe mitral regurgitation who are unsuitable for surgery.

Not a fit: Patients who are not symptomatic or have mild mitral regurgitation may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients with severe mitral regurgitation who are not candidates for surgery.

How similar studies have performed: Other studies have shown promise with transcatheter approaches for mitral valve issues, suggesting potential for success with this novel intervention.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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.

Exclusion Criteria (Abbreviated List):

* 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.
* Evidence of current left ventricular ejection fraction (LVEF) ≤ 25%.
* Concurrent medical condition with a life expectancy of less than 12 months.
* Transcatheter aortic repair or replacement within 90 days prior to the index procedure.
* Percutaneous coronary intervention (PCI) within 90 days prior to the index procedure.

Where this trial is running

Phoenix, Arizona and 28 other locations

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Incompetence, Mitral Valve Regurgitation, Mitral Incompetence, TMVR, Functional Regurgitation, Degenerative Regurgitation

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.