MedTrace Logo

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

NCT05391802 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-05-26

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2022-06-30
Completion
2024-06-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05391802 on ClinicalTrials.gov