Evaluating the AltaValve for treating severe mitral valve regurgitation

AltaValve Early Feasibility Study Protocol

This study is testing a new device called AltaValve to see if it can safely help people with severe mitral valve regurgitation who can't have regular heart surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: 4C Medical Technologies, Inc. (industry)
• Locations: 12 sites (Tucson, Arizona and 11 other locations)
• Trial ID: NCT03997305 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with symptomatic severe mitral regurgitation and deemed high risk for open-heart surgery.

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

Why it matters

Potential benefit: If successful, this could provide a less invasive treatment option for patients with severe mitral valve regurgitation who are at high surgical risk.

How similar studies have performed: Other studies have shown promise with transcatheter approaches for mitral valve repair and replacement, indicating potential for success with this novel device.

Eligibility criteria

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 this trial is running

Tucson, Arizona and 11 other locations

• 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)
• Morristown Medical Center — Morristown, New Jersey, United States (RECRUITING)
• Atrium Health — Charlotte, North Carolina, United States (RECRUITING)
• Oklahoma Heart Hospital — Oklahoma City, Oklahoma, United States (RECRUITING)
• Baptist Memorial Hospital - Memphis — Memphis, Tennessee, United States (RECRUITING)
• Houston Methodist Hospital — Houston, Texas, United States (RECRUITING)
• Baylor Scott & White — Plano, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Philippe Genereux, MD — Morristown Medical Center
• Study coordinator: Adam Lawrence

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