Transcatheter Versus Standard Surgical Mitral Valve Operation for Secondary Mitral Regurgitation (NCT05090540) | Clinical Trial Compass
By InvitationNot Applicable
Transcatheter Versus Standard Surgical Mitral Valve Operation for Secondary Mitral Regurgitation
France600 participantsStarted 2017-06-01
Plain-language summary
The mechanical intervention is treating secondary mitral regurgitation (SMR) which may be performed using the standard open surgical approach or transcatheter edge to edge repair (TEER). The key question of this study is to establish the difference in left ventricular reverse remodeling after adjustment for death, as assessed by means of the left ventricular end-systolic dimension(LVESD), all-cause and cause-specific (cardiac vs noncardiac) mortality in patients who received the TEER vs the standard surgical procedure for SMR.
Who can participate
Age range
18 Years – 90 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:
* Adult
* Ischemic NoIschemic cardiomyopathy
* EROA\> 0,2 cm2 or Regurgitant Volume \> 30 ml (ESC guidelines).
* EROA ≥ 0.4 cm2 with tethering (ACC/AHA)
* MR Grade 3/4
* Eligible for TEE, surgical repair and replacement of mitral valve
* Coronary artery disease with or without the need for coronary revascularization
* Average value LVEDD 62 mm LVEF 42%
Exclusion Criteria:
* Pediatric
* Any echocardiographic evidence of structural (chordal or leaflet) mitral-valve disease
* ruptured papillary
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.