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MiCLASP Post Market Clinical Follow-Up (PMCF) Study

NCT04430075 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2025-06-26

No results posted yet for this study

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 in transcatheter mitral valve repair.

Conditions

  • Mitral Regurgitation
  • Mitral Insufficiency

Interventions

DEVICE

Edwards PASCAL Transcatheter Valve Repair System and Edwards PASCAL Precision Transcatheter Valve Repair System

Transcatheter Valve Repair with Edwards PASCAL and PASCAL Precision System

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Philipp Lurz, Prof.Dr.med. · Johannes Gutenberg University Mainz

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-23
Primary Completion
2025-12-31
Completion
2031-03-31
FDA Device
Yes

Countries

  • Austria
  • Germany
  • Greece
  • Italy
  • Netherlands
  • Poland
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04430075 on ClinicalTrials.gov