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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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