Status:

COMPLETED

Edwards PASCAL Transcatheter Valve Repair System Registry

Lead Sponsor:

Edwards Lifesciences

Conditions:

Mitral Valve Insufficiency

Eligibility:

All Genders

18+ years

Brief Summary

This registry will collect prospective and retrospective clinical data on patients treated with the Edwards PASCAL Transcatheter Valve Repair System outside of the Post-Market Clinical Follow-up (PMCF...

Detailed Description

Patients treated per standard of care at their medical facilities and a written informed consent will be collected to allow the data to be collected. This registry intends to enroll patients under com...

Eligibility Criteria

Inclusion

  • Patient signs informed consent to participate in the registry
  • Patient is intended to or has received the PASCAL device

Exclusion

  • Patient does not consent to participate
  • Patient is part of an ongoing Edwards Pre or Post Market Clinical study for the PASCAL Transcatheter Valve Repair System.

Key Trial Info

Start Date :

May 27 2019

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

May 10 2021

Estimated Enrollment :

220 Patients enrolled

Trial Details

Trial ID

NCT04443218

Start Date

May 27 2019

End Date

May 10 2021

Last Update

July 26 2024

Active Locations (14)

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Page 1 of 4 (14 locations)

1

LMU Klinikum der Universität München

München, Bavaria, Germany, 81377

2

Immanuel Klinikum Bernau

Bernau bei Berlin, Brandenburg, Germany, 16321

3

Universitätsklinikum Gießen

Giessen, Hesse, Germany, 35392

4

Georg-August-Universität Göttingen, Universitätsmedizin Göttingen

Göttingen, Lower Saxony, Germany, 37075

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