Status:
RECRUITING
MiCLASP Post Market Clinical Follow-Up (PMCF) Study
Lead Sponsor:
Edwards Lifesciences
Conditions:
Mitral Regurgitation
Mitral Insufficiency
Eligibility:
All Genders
18+ years
Brief Summary
This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System...
Detailed Description
The objectives of this clinical study are to collect data on the safety of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in tr...
Eligibility Criteria
Inclusion
- Mitral TEER patients eligible per the current approved indication after Heart Team discussion and agreement
- Patient is willing and able to attend all follow-up visits and to perform all tests
- Provision of written informed consent
Exclusion
- Patients are not eligible per the current Instructions for Use
- Non-elective or emergency TEER procedure for mitral regurgitation
- Patients in ICU prior to the index procedure
Key Trial Info
Start Date :
August 23 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2031
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04430075
Start Date
August 23 2019
End Date
March 31 2031
Last Update
June 26 2025
Active Locations (37)
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1
Medizinische Universität Wien/AKH Wien
Vienna, Austria, 1090
2
Universitäts-Herzzentrum Freiburg Campus Bad Krozingen
Bad Krozingen, Baden-Wurttemberg, Germany, 79189
3
Universität Tuebingen
Tübingen, Baden-Wurttemberg, Germany, 72074
4
Uniklinikum Ulm
Ulm, Baden-Wurttemberg, Germany, 89081