AltaValve Pivotal Trial
Purpose
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.
Conditions
- Mitral Regurgitation
- Mitral Insufficiency
- Mitral Valve Incompetence
- Mitral Valve Regurgitation
- Mitral Incompetence
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Primary Cohort |
Designed to evaluate the safety and performance of the AltaValve System for the treatment of moderate-to-severe or severe MR in a targeted patient population without at least moderate mitral annular calcification (MAC). |
|
Experimental Mitral Annular Calcification Cohort (MAC) |
Designed to evaluate the safety and performance of the AltaValve System for the treatment of moderate-to-severe or severe MR in a targeted patient population with moderate to severe MAC. |
|
Recruiting Locations
Houston, Texas 77030
More Details
- Status
- Recruiting
- Sponsor
- 4C Medical Technologies, Inc.