Research Study: AltaValve Pivotal Trial
Condition:
Valvular Disease (Heart Valve Disease), Mitral Valve Regurgitation
Study Sponsor:
4C Medical Technologies, Inc.
Study Investigator:
Dr. Paul Sorajja
Study Contact:
Every research study comes with its own unique risks and benefits; the study team will assess whether you’re an eligible candidate and ensure you’re provided with all the information you need to decide if participating is right for you.
About this Study:
This is a prospective, single arm, multicenter, clinical trial designed to evaluate the safety and performance of the AltaValve System for the treatment of mitral regurgitation in a targeted patient population.
Eligibility 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.
