NCT04919980

TVMR With the INNOVALVE System Trial - Early Feasibility Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study to evaluate the safety and performance of the INNOVALVE system

Detailed description

The study is a multi-center, First-In-Human, prospective, single arm early feasibility study to evaluate the safety and performance of the INNOVALVE system

Conditions

• Mitral Valve Regurgitation (Degenerative or Functional)

Interventions

Type	Name	Description
DEVICE	INNOVALVE system	INNOVALVE system

Timeline

• Start date: 2022-09-01
• Primary completion: 2026-07-01
• Completion: 2031-07-01
• First posted: 2021-06-09
• Last updated: 2026-01-30

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated device study