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

Mitral Regurgitation Clinical Trial

Official title:
Prospective Analysis of the Feasibility of the PASCAL Spacer Technology for Transcatheter Mitral Valve Repair in an All-comers Cohort

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04473092
Study type Observational
Source University Hospital, Essen
Contact
Status Completed
Phase
Start date July 20, 2020
Completion date September 30, 2022
View Details
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