Abrogation of Mitral Regurgitation Using the MitraClip System in High-Risk Patients Unsuitable fo… (NCT01431222) | Clinical Trial Compass
UnknownPhase 4
Abrogation of Mitral Regurgitation Using the MitraClip System in High-Risk Patients Unsuitable for Surgery
Germany100 participantsStarted 2011-09
Plain-language summary
The primary objective in this randomized trial is to evaluate the safety and efficacy of a MitraClip treatment in symptomatic patients with severe mitral regurgitation in comparison to the previous default medical treatment - in a study population who is not amenable for the conventional surgical approach as current gold standard.
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:
* age ≥ 18 years
* signed written consent
* symptomatic patients (NYHA-stadium ≥ III) for at least 3 months with an exploited medical heart insufficiency therapy
* increased perioperative risk with a logistic EuroScore ≥ 15 or STS-Score ≥ 15
* MR grade ≥ 2, amenable for MitraClip intervention assessed by an experienced interventional cardiologist
* Affirmation of in-operability by a "Heart-Team" consisting of either 1 cardiac surgeon and 1 cardiologist or 3 cardiologists
Exclusion Criteria:
* one essential cardiovascular event in the past 6 weeks; i. e. myocardial infarction, stroke, shock, cardiac decompensation, or the necessity of catecholamine therapy for haemodynamic stabilisation
* implantation of a biventricular pacemaker-device for cardiac resynchronisation therapy in the past 3 months
* solid tumor with a live expectancy \< 1 year
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
Improvement of Dyspnoea of at least one class (NYHA-Classification)