MiCLASP Post Market Clinical Follow-Up (PMCF) Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEdwards Lifesciences
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Edwards PASCAL Transcatheter Valve Repair System and Edwards PASCAL Precision Transcatheter Valve Repair System
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov