NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT06702527

TerminatedN/A

Sponsor: Institut für Pharmakologie und Präventive Medizin

Conditions: Mitral Regurgitation Functional, Heart Failure, M-TEER

Interventions: Mitral transcatheter edge-to-edge repair

Countries: Germany

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (2)

Cologne, Germany
Trier, Germany