Evaluating the AltaValve for treating severe mitral valve 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 study is a prospective, single-arm, multicenter evaluation of the AltaValve device aimed at treating patients with moderate to severe mitral valve regurgitation who are at high risk for conventional open-heart surgery. It focuses on assessing the safety and performance of the device in a population that may not have other viable treatment options. Participants will be monitored for outcomes related to their heart condition and overall health following the intervention.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subjects ≥ 18 years of age.
2. Subjects symptomatic New York Heart Association (NYHA) II-IV.
3. Subjects with severe MR as documented by echo.
4. 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).

Abbreviated Exclusion Criteria:

1. Inability to understand the study or a history of non-compliance with medical advice.
2. Unwilling or unable to sign the Informed Consent Form (ICF).
3. History of any cognitive or mental health status that would interfere with study participation.
4. 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.)).
5. Female subjects who are pregnant or planning to become pregnant within the study period.
6. Known hypersensitivity or contraindication to aspirin, heparin, or Warfarin without adequate alternative medications.
7. Known hypersensitivity to nitinol (i.e., nickel allergy) that cannot be adequately medicated.
8. Known hypersensitivity to contrast media that cannot be adequately medicated.
9. 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).
10. Concurrent medical condition with a life expectancy of less than 12 months.
11. Prior mitral valve repair/replacement (excluding prior surgical mitral valve repair, annuloplasty, or MitraClip not interfering with AltaValve placement).

Where it's running

• Tucson Medical Center
  Tucson, Arizona, United States Recruiting
• Los Robles Regional Medical Center
  Thousand Oaks, California, United States Recruiting
• MedStar Washington Hospital
  Washington, District of Columbia, United States Recruiting
• Tampa General Hospital
  Tampa, Florida, United States Recruiting
• Emory University
  Atlanta, Georgia, United States Recruiting
• Cardiovascular Institute of the South
  Houma, Louisiana, United States Recruiting

Study contacts

• Principal investigator: Philippe Genereux, MD — Morristown Medical Center
• Study coordinator: Adam Lawrence
• Email: AltaValveEFS@4CMed.com
• Phone: +1-727-318-2203

Similar studies

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

• Evaluation of the AltaValve System for treating mitral regurgitation

  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.

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• How TAVI and M‑TEER affect sleep‑disordered breathing

  This will see if adults with aortic stenosis or mitral regurgitation who undergo TAVI or M‑TEER have improvements in sleep‑disordered breathing six months after their procedure.

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• Posterior Mitral Leaflet Replacement to Reduce Mitral Regurgitation

  This early feasibility trial tests the MR-ace Implant and Delivery System to see if it can reduce symptoms and leaks in people with moderate-to-severe functional mitral regurgitation.

  Recruiting Polares Medical SA · Atlanta, Georgia and 2 other locations · NCT07517588

• Replacing the native mitral valve with the ReValve System

  This study will test whether replacing the native mitral valve with the ReValve System helps adults with symptomatic, clinically significant mitral regurgitation who are appropriate candidates for mitral valve surgery.

  Recruiting at 3 sites Phase 1 ReValve Solutions Inc. · Tbilisi and 2 other locations · NCT07450911

• Transcatheter Mitral and Tricuspid Interventions and Cardiac MRI Registry

  This study will collect imaging and clinical data from adults undergoing transcatheter mitral or tricuspid procedures to see how their heart structure and function change over time using MRI and advanced ultrasound.

  Recruiting Centro Cardiologico Monzino · Milan, Milan · NCT07370467

• Mitral and Tricuspid Valve-in-Valve/Valve-in-Ring Registry in Asia-Pacific

  This registry tracks people in Asia-Pacific who have had or will have valve-in-valve or valve-in-ring procedures for mitral or tricuspid valve disease to learn about outcomes and safety after these transcatheter approaches.

  Recruiting Prince of Wales Hospital, Shatin, Hong Kong · Hong Kong, Shatin · NCT07296016

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.