About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Degenerative mitral regurgitation
Emergency procedure
Re-do or concomitant (mitral/tricuspid) procedures
Patients on maximum dose GDMT
Trial design
Treatments tested in this trial
- Mitral transcatheter edge-to-edge repair