NCT04820764

EFS of the CardioMech MVRS

Early Feasibility Study of the CardioMech Mitral Valve Repair System (MVRS)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: CardioMech AS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.

Detailed description

The purpose of the clinical study is to obtain clinical data on the CardioMech Mitral Valve Repair System (MVRS) in patients diagnosed with moderate to severe (≥3+) or severe (≥4+), symptomatic, degenerative mitral regurgitation and who are determined to be at intermediate or high surgical risk for mitral valve repair, as assessed by the site's multidisciplinary heart team.

Conditions

• Mitral Regurgitation

Interventions

Type	Name	Description
DEVICE	CardioMech MVRS	CardioMech MVRS

Timeline

• Start date: 2021-07-27
• Primary completion: 2026-09-01
• Completion: 2031-09-01
• First posted: 2021-03-29
• Last updated: 2026-02-10

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated device study