NCT04430075

MiCLASP Post Market Clinical Follow-Up (PMCF) Study

Transcatheter Repair of Mitral Regurgitation With Edwards PASCAL Transcatheter Valve Repair System: A European Prospective, Multicenter Post Market Clinical Follow-Up (PMCF)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Mitral Regurgitation
• Mitral Insufficiency

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-08-23
• Primary completion: 2025-12-31
• Completion: 2031-03-31
• First posted: 2020-06-12
• Last updated: 2025-06-26

Locations

37 sites across 9 countries: Austria, Germany, Greece, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study