Feasibility Study of the Tendyne Mitral Valve System in Mitral Annular Calcification

NCT03539458 NA COMPLETED Results posted

This study is a prospective, single-arm, multi-center feasibility clinical study of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe mitral regurgitation and severe mitral annular calcification (MAC). Subjects satisfying the study inclusion/exclusion criteria will undergo a procedure to implant the Tendyne mitral valve replacement device.

Details

Lead sponsor	Abbott Medical Devices
Phase	NA
Status	COMPLETED
Enrolment	11
Start date	Wed Oct 10 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Tue Jun 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Mitral Regurgitation
• Mitral Insufficiency
• Mitral Annular Calcification
• Mitral Annulus Calcification
• Cardiovascular Diseases
• Valve Heart Disease
• Heart Valve Diseases
• Heart Valve Calcification
• Mitral Valve Disease

Interventions

• Tendyne Mitral Valve System

Countries

United States