NCT05391802

The Multicenter Clinical Trial of a Novel TEER Decive (V-CLASP Trial)

A Multicenter, Prospective, Single-arm Objective Performance Criteria Trial to Evaluate the Safety and Efficacy of the Transcatheter Mitral Valve Repair System: ValveClasp® in the Treatment of Moderate to Severe Mitral Regurgitation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single-group, prospective, multicenter clinical research using the single-arm objective performance criteria. Patients with moderate to severe mitral regurgitation and a high surgical risk will be treated with ValveClasp®, a novel transcatheter mitral edge-to-edge repair system. The subjects will be followed postoperatively, before discharge, for one month, six months, and twelve months. immediately following operation, before discharge, and at 1, 6, and 12 months after surgery, with follow-up at 2, 3, 4, and 5 years. The follow-ups began immediately before discharge and continued for one month, six months, and twelve months after surgery, with extensions to two, three, four, and five years.

Conditions

• Mitral Regurgitation

Interventions

Type	Name	Description
DEVICE	Transcatheter mitral valve repair	Transcatheter mitral valve repair (TMVr) is a minimally invasive procedure. Doctors place a thin tube (calleda catheter) into a large vein to reach your heart. A clip is then placed onto the center of your mitral valve. The valve continues to open and close, allowing blood to flow through while reducing MR.

Timeline

• Start date: 2022-06-30
• Primary completion: 2022-06-30
• Completion: 2024-06-30
• First posted: 2022-05-26
• Last updated: 2022-05-26