NCT03170349

The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety, performance and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System.

Detailed description

The purpose of this study is to assess the safety, performance and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System. This is a multi-center, multi-national, prospective, single arm, safety, performance and clinical outcomes study.

Conditions

• Mitral Valve Regurgitation

Interventions

Type	Name	Description
DEVICE	Mitral Valve Repair	Minimal Invasive Transcatheter Mitral Valve Repair

Timeline

• Start date: 2017-06-27
• Primary completion: 2020-07-30
• Completion: 2025-05-27
• First posted: 2017-05-31
• Last updated: 2026-02-05
• Results posted: 2021-12-01

Locations

17 sites across 7 countries: United States, Australia, Canada, Germany, Greece, Italy, Switzerland

Regulatory

• FDA-regulated device study