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.
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
Degenerative mitral regurgitation
Emergency procedure
Re-do or concomitant (mitral/tricuspid) procedures
Patients on maximum dose GDMT
Patients with severe functional and mixed-type mitral regurgitation with optimized GMDT undergoing M-TEER (using the PASCAL system)
Case-only
Prospective
Mitral transcatheter edge-to-edge repair
Procedure/SurgeryMitral transcatheter edge-to-edge repair with the PASCAL system
Rate of Heart Failure hospitalizations after mitral transcatheter edge-to-edge repair (M-TEER)
Number of 6- and 12-months heart failure (HF) hospitalizations post M-TEER procedure compared to 12- and 6-months historical HF hospitalization prior the index procedure
New York Heart Association (NYHA) class
NYHA class at baseline and 6-months follow-up
6-minute walk test
6-minute walk test at baseline and 6-months follow-up
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