What is the Purpose of this Study?
The purpose of this study is to evaluate the safety and effectiveness of an experimental device called the AltaValve System in people with moderate-to-severe and severe mitral regurgitation. The study aims to determine whether the device can help treat a leaky valve; it involves a procedure that is less invasive than open heart replacement of the mitral valve. Study procedures include transcatheter mitral valve replacement procedure and clinic visits.
A smaller study to assess the safety of the AltaValve System was already completed; this study is being conducted to confirm AltaValve System’s long-term effectiveness. The AltaValve is a self-expandable device created to fit the patient’s heart. The tissue valve is a man-made valve that imitates the patient’s own mitral valve leaflets (leaf-like structures that help control the blood flow in the heart). The fabric and tissue are intended to reduce or stop the leakage of the mitral valve.
Eligibility
- * 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.
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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.
- * 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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Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
AltaValve Pivotal Trial Protocol