A Multicenter, Randomized, Controlled Study to Assess Mitral vAlve reconsTrucTion for advancEd In… (NCT02371512) | Clinical Trial Compass
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A Multicenter, Randomized, Controlled Study to Assess Mitral vAlve reconsTrucTion for advancEd Insufficiency of Functional or iscHemic ORigiN
Germany210 participantsStarted 2015-02
Plain-language summary
Study to assess mitral valve therapy for advanced insufficiency of functional or ischemic origin in patients with moderate-to-severe mitral regurgitation (MR) of primarily functional pathology and reduced left ventricular function considered to be at high surgical risk
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:
* Clinically significant mitral regurgitation of primarily functional pathology
* Left Ventricular Ejection Fraction (LVEF) ≥20% determined by echocardiography
* High surgical risk as determined by Heart Team consensus
* Documented New York Heart Association Class II to Class IV heart failure, despite optimal standard of care therapy
* Written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
Exclusion Criteria:
* Echocardiographic evaluation not available or not suitable for analysis at baseline
* Severe tricuspid regurgitation according to current guidelines5
* Other severe valve disorders requiring intervention according to current
* Coronary revascularization or cardiac resynchronization (CRT) device implantation within 1 month before the procedure
* Patient not amenable for mitral valve surgery/ percutaneous mitral valve reconstruction as judged by Heart Team
* Key information from patients (e.g. NYHA, MR grade) not available
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
Composite of death, rehospitalisation for heart failure, reintervention (repeat operation or repeat intervention), assist device implantation and stroke (whatever is first) 12 months post intervention; equivalently "freedom from event"