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

  • STATUS
    Recruiting
  • participants needed
    80
  • sponsor
    University Hospital, Essen
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Updated on 16 February 2024
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mitral valve repair

Summary

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.

Details
Condition VALVULAR HEART DISEASE, Mitral Regurgitation
Age 18years - 100years
Treatment TMVR
Clinical Study IdentifierNCT04473092
SponsorUniversity Hospital, Essen
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

<18yry
Subject does not provide full consent
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