Prospective Analysis of the Feasibility of the PASCAL Spacer Technology for Transcatheter Mitral Valve Repair in an All-comers Cohort (OneForAll)

University Hospital Essen

Status

Completed

Conditions

Mitral Regurgitation

Treatments

Device: TMVR

Study type

Observational

Funder types

Other

Identifiers

NCT04473092

20-9223-BO

Details and patient eligibility

About

To identify changes on mitral valve morphology and functionality by the application of the PascalTM in MR.

Full description

Transcatheter mitral valve repair (TMVR) in mitral regurgitation (MR) is increasingly applied in patients on high surgical risk. Interventional mitral valve repair can be applied is routinely applied in primary and secondary mitral regurgitation. While the edge-to-edge technique has been the solely available technlology in the marked for the last years, the recently introduced PascalTM technology represents a novel concept and is characterized by a central spacer, wider paddles, and larger dimensions. Implications of implantation of the PascalTM device on the mitral valve morphology and functionality concerning potential changes on mitral regurgitation as well as changes on mitral valve orifice area are to date not fully understood. The current study will identify anatomical changes to optimize ideal patient selection and optimal treatment approaches of the PASCALTM device.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

• All patients who undergo TVMR for MR (age >18yrs) at the PI´s site

Exclusion criteria