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

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

Recruiting
18 years and older
All
Phase N/A

Overview

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

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.

Eligibility

Inclusion Criteria:

All patients who undergo TVMR for MR (age >18yrs) at the PIs site

Exclusion Criteria:

  • <18yry
  • Subject does not provide full consent

Study details
    VALVULAR HEART DISEASE
    Mitral Regurgitation

NCT04473092

University Hospital, Essen

16 February 2024

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