Mitral Incompetence, Mitral Insufficiency, Mitral Regurgitation, Mitral Valve Incompetence, Mitral Valve Regurgitation
Conditions
Keywords
Mitral Regurgitation, TMVR, Functional Regurgitation, Degenerative Regurgitation, Transcatheter Mitral Valve Replacement, Primary Regurgitation, Secondary Regurgitation
Brief 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.
Interventions
DEVICEAltaValve System.
Transcatheter Mitral Valve Replacement.
Sponsors
4C Medical Technologies, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 baseline required tests. * Percutaneous coronary intervention (PCI) within 30 days prior to the index procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of all-cause mortality or heart failure hospitalization. | 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality, disabling stroke, acute kidney injury (stage 3 or with renal replacement), mitral valve re-intervention (surgical or transcatheter), major bleeding requiring intervention. | 30 Days or hospital discharge (whichever is longer). | Composite. |
| Technical success. | Day 0. | Technical success will be considered achieve when all of the following are present: * Successful application of the delivery system as intended. * Successful device placement. * Reduction in mitral regurgitation grade to ≤ 2+. |
| Mitral valve re-intervention. | At 30 days, 6 months, 1 year, and annually thereafter for up to 5 years. | Mitral valve re-intervention after index procedure |
| Changes in Kansas City Cardiomyopathy Questionnaire (KCCQ). | 6 months and 1 year. | Quality of life improvement. |
| Changes in Six-minute walk test (6MWT). | 6 months and 1 year. | Quality of life improvement. |
| New pacemaker rate. | 1 month, 6 months and 1 year. | — |
Countries
Canada, France, Germany, Greece, Poland, Spain, United States
Outcome results
None listed