RecruitingNot ApplicableNCT06465745
AltaValve Pivotal Trial
Sponsor
4C Medical Technologies, Inc.
Enrollment
450 participants
Start Date
Sep 3, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
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
Min Age: 18 Years
Inclusion Criteria4
- 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 Criteria12
- 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.
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Interventions
DEVICEAltaValve System.
Transcatheter Mitral Valve Replacement.
Locations(29)
View Full Details on ClinicalTrials.gov
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NCT06465745
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