AltaValve Early Feasibility Study Protocol

Launched by 4C MEDICAL TECHNOLOGIES, INC. · Jun 21, 2019

Keywords

ClinConnect Summary

The AltaValve Early Feasibility Study is a clinical trial aimed at testing a new treatment called AltaValve for patients with moderate to severe mitral valve regurgitation. This condition occurs when the heart's mitral valve doesn’t close properly, causing blood to flow backward and leading to symptoms like shortness of breath and fatigue. The trial is designed for individuals who are at high risk for serious complications from traditional open-heart surgery, which makes them ideal candidates for this less invasive option.

To participate in the study, patients must be at least 18 years old, show symptoms of the condition, and have severe mitral valve regurgitation confirmed by an ultrasound of the heart. They should also be considered high-risk for surgery by a team of heart specialists. Participants can expect to receive close monitoring during the trial to ensure their safety and to assess how well the AltaValve works. This study is currently recruiting participants, and it’s important for potential candidates to discuss their eligibility with their healthcare provider.

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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).