Prediction of Reverse Remodeling and Outcome in Patients With Severe Secondary Mitral Valve Regurgitation Undergoing Transcatheter Edge-to-edge Mitral Valve Repair

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The investigators' hypothesis is that CMR tissue characterization and myocardial function analysis acquired by CMR feature tracking technique predict reverse remodeling in patients with severe secondary mitral regurgitation (MR) undergoing transcatheter mitral edge-to-edge repair.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with severe secondary MR characterized, according to the European guidelines and recommendations, by a regurgitant volume ≥30 mL/beat or an effective regurgitant orifice ≥20 mm².

• Symptomatic patients with New York Heart Association Class ≥II.

• Left ventricular ejection fraction between 15% and 50%.

• Optimal standard of care therapy for heart failure according to investigator.

• Not eligible for a mitral surgery intervention according to the Heart Team.

• Patients who have the ability to understand the requirements of the study and provide written consent/assent to participate and agree to abide by the study requirements.

Locations
Other Locations
Switzerland
Department of Cardiology, University Hospital Bern, Inselspital, Bern
RECRUITING
Bern
Contact Information
Primary
Christoph MD Gräni, PHD
christoph.graeni@insel.ch
+41 31 632 4508
Time Frame
Start Date: 2021-08-04
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 300
Treatments
Experimental: Treatment Arm
Patients undergoing transcatheter mitral edge-to-edge repair in this single-arm study.
Related Therapeutic Areas
Sponsors
Collaborators: Triemli Hospital, Cardiocentro Ticino, University Hospital, Basel, Switzerland
Leads: Insel Gruppe AG, University Hospital Bern

This content was sourced from clinicaltrials.gov