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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitut für Pharmakologie und Präventive Medizin

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

Treatment groups

100 Participants
are divided into 1 treatment group