Evaluation of the AltaValve System for treating mitral regurgitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 baseline required tests.
* Percutaneous coronary intervention (PCI) within 30 days prior to the index procedure.

Where it's running

• Banner University Medical Center
  Phoenix, Arizona, United States Recruiting
• Abrazo Arizona Heart Hospital
  Phoenix, Arizona, United States Recruiting
• Dignity Health; St. Joseph's Hospital and Medical Center
  Phoenix, Arizona, United States Recruiting
• TMC Healthcare
  Tucson, Arizona, United States Recruiting
• Scripps Health
  La Jolla, California, United States Recruiting
• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting

+8 more sites. See ClinicalTrials.gov for the full list.

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Mitral valve replacement with the SATURN TMVR system for severe mitral regurgitation

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.