Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patien… (NCT07227675) | Clinical Trial Compass
CompletedNot Applicable
Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional MR
United States162 participantsStarted 2017-10-23
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 precl…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety end point: Freedom from death
Timeframe: through 5 years
2
Safety end point: Freedom from Myocardial Infarction (MI)