Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional MR (COAPT CAS)

Abbott

Status

Completed

Conditions

Mitral Valve Regurgitation

Mitral Regurgitation

Treatments

Device: MitraClip® NT System

Study type

Interventional

Funder types

Industry

Identifiers

NCT07227675

11- 512

Details and patient eligibility

About

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).

Enrollment

162 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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