NCT04281940

Chordal Repair for Transcatheter Mitral Valve Repair (TMVr)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Pipeline Medical · Industry
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

A multi-center evaluation of the Pipeline chordal repair system for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve repair.

Detailed description

The proposed study is a prospective, multi-center, interventional investigation enrolling up to 30 subjects in multiple sites in Latin America and Eastern Europe. The primary objective of this study is to collect preliminary information on the performance and safety of the Pipeline Chordal Repair System in percutaneous reduction of significant mitral regurgitation (MR ≥ moderate) due to primary abnormality of the mitral apparatus \[degenerative MR\].

Conditions

• Degenerative Mitral Valve Disease
• Mitral Valve Regurgitation

Interventions

Type	Name	Description
DEVICE	Transcatheter implantation of chordal repair system	Implantation of anchor via transcatheter delivery system to delivery chordal repair system tethering the mitral leaflets to the ventricle

Timeline

• Start date: 2022-03-18
• Primary completion: 2023-06-07
• Completion: 2024-05-01
• First posted: 2020-02-24
• Last updated: 2024-10-15

Locations

4 sites across 3 countries: Georgia, Paraguay, Serbia