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MiCLASP Post Market Clinical Follow-Up (PMCF) Study

MiCLASP Post Market Clinical Follow-Up (PMCF) Study

Recruiting
18 years and older
All
Phase N/A
  • Technical (Original)
  • Simplified (AI rewritten)

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Overview

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.

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 transcatheter mitral valve repair and on the effectiveness of the Edwards PASCAL System and Edwards PASCAL Precision System in improving MR, functional status and quality of life in a post market setting.

Eligibility

Inclusion Criteria:

  1. Mitral TEER patients eligible per the current approved indication after Heart Team discussion and agreement
  2. Patient is willing and able to attend all follow-up visits and to perform all tests
  3. Provision of written informed consent

Exclusion Criteria:

  1. Patients are not eligible per the current Instructions for Use
  2. Non-elective or emergency TEER procedure for mitral regurgitation
  3. Patients in ICU prior to the index procedure

Study details
    Mitral Regurgitation
    Mitral Insufficiency

NCT04430075

Edwards Lifesciences

27 January 2024

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