Mitral Regurgitation, Mitral Valve Regurgitation
Conditions
Keywords
Functional Mitral Regurgitation, Mitral Valve Regurgitation, Symptomatic Heart Failure, COAPT CAS
Brief summary
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).
Interventions
DEVICEMitraClip® NT System
The MitraClip NT System is intended to treat heart failure patients with symptomatic ischemic or non-ischemic functional MR
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who have national Medicare coverage by CMS * Symptomatic functional MR (≥3+) due to cardiomyopathy of either ischemic or non-ischemic etiology * Subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, mitral regurgitation and heart failure * Subject has had at least one hospitalization for heart failure in the 12 months prior to subject registration and/or a corrected BNP ≥300 pg/ml or corrected NT-proBNP ≥1500 pg/ml * New York Heart Association (NYHA) Functional Class II, III or ambulatory IV * Surgery will not be offered as a treatment option and medical therapy is the intended therapy for the subject * Left Ventricular Ejection Fraction (LVEF) is ≥20% and ≤50% * Left Ventricular End Systolic Dimension (LVESD) is ≤70 mm
Exclusion criteria
* Untreated clinically significant coronary artery disease requiring revascularization * Coronary artery bypass grafting (CABG) within prior 30 days * Percutaneous coronary intervention within prior 30 days * Tricuspid valve disease requiring surgery * Aortic valve disease requiring surgery * Chronic Obstructive Pulmonary Disease (COPD) requiring continuous home oxygen therapy or chronic outpatient oral steroid use * Cerebrovascular accident within prior 30 days * Severe symptomatic carotid stenosis (\> 70% by ultrasound) * Carotid surgery within prior 30 days * Mitral valve orifice area \< 4.0 cm2 * Leaflet anatomy which may preclude MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in MR by the MitraClip
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety end point: Freedom from death | through 5 years |
| Safety end point: Freedom from Myocardial Infarction (MI) | through 5 years |
| Safety end point: Freedom from stroke | through 5 years |
| Safety end point: Heart Failure Hospitalization | through 5 years |
| Recurrent Heart Failure Hospitalization | through 5 years |
Countries
United States
Outcome results
None listed