NCT02321514

Expanded Clinical Study of the Tendyne Mitral Valve System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 191 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and performance of the Tendyne Mitral Valve System in the treatment of severe mitral regurgitation in patents with functional disability greater than or equal to NYHA Class II, who are not suitable candidates for surgical replacement with otherwise available devices. Follow-up evaluations will be conducted through 5 years post implantation.

Conditions

• Mitral Valve Regurgitation

Interventions

Type	Name	Description
DEVICE	Tendyne Mitral Valve System	Patients will undergo transcatheter mitral valve replacement using Tendyne Mitral Valve system

Timeline

• Start date: 2014-11-01
• Primary completion: 2020-07-01
• Completion: 2025-04-01
• First posted: 2014-12-22
• Last updated: 2025-07-17
• Results posted: 2021-09-02

Locations

40 sites across 10 countries: United States, Australia, France, Germany, Italy, Netherlands, Norway, Sweden, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study