The COAPT Continued Access Study (CAS) is an extension of the COAPT RCT under the same IDE (G120024). COAPT CAS was a single-arm, prospective, multicenter continued access registry that enrolled heart failure patients with secondary mitral regurgitation who remained symptomatic despite optimal guideline-directed medical therapy (GDMT). The objective of the COAPT CAS is to continue the evaluation of safety and effectiveness of the MitraClip NT System under more "real world" conditions in patients who meet the COAPT inclusion/exclusion criteria and who have national Medicare coverage by the Centers for Medicare and Medicaid Services (CMS).
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Safety end point: Freedom from death
Timeframe: through 5 years
Safety end point: Freedom from Myocardial Infarction (MI)
Timeframe: through 5 years
Safety end point: Freedom from stroke
Timeframe: through 5 years
Safety end point: Heart Failure Hospitalization
Timeframe: through 5 years
Recurrent Heart Failure Hospitalization
Timeframe: through 5 years