Optimizing Clinical Outcomes in Patients Undergoing Mitral Transcatheter Edge-to-edge Repair (M-TEER) for Severe Functional Mitral Regurgitation Towards Improved Guideline-directed Medical Therapy
Germany100 participantsStarted 2025-06-01
Plain-language summary
A multi-centre, prospective, observational pilot registry in patients undergoing mitral valve repair for severe functional mitral regurgitation to report the heart failure drug therapy and dosing before the mitral valve procedure and afterwards to assess whether the recommended maximal dose of medication is administered. This maximal dose, although recommended, might not be tolerated well by patients and can cause side-effects. Researchers will determine whether the mitral valve repair procedure might have a possible effect on increasing the drug therapy towards the recommended optimal doses.
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:
* mitral transcatheter edge-to-edge repair (M-TEER) patients treated with the PASCAL system (≥ 18 years) as per the current approved indication and local Heart Team decision
* Severe functional and mixed-type mitral regurgitation with LV-EF \< 50%
* Patient with optimized guideline-directed medical therapy (GDMT): A minimum of 3 points in the pre-defined GMDT scoring system
* Provision of written informed consent
Exclusion Criteria:
* Degenerative mitral regurgitation
* Emergency procedure
* Re-do or concomitant (mitral/tricuspid) procedures
* Patients on maximum dose GDMT
* Atrial functional mitral regurgitation (FMR)
* Coronary revascularisation within the last 3 months
* Pregnant woman
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
Rate of Heart Failure hospitalizations after mitral transcatheter edge-to-edge repair (M-TEER)
Timeframe: 6 and 12 months
Trial details
NCT IDNCT06702527
SponsorInstitut für Pharmakologie und Präventive Medizin