NCT02974881

HighLife™ Transcatheter Mitral Valve Replacement System Study

HighLife™ Transcatheter Mitral Valve Replacement System for Severe Mitral Regurgitation in Patients at High Surgical Risk

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: HighLife SAS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multicenter feasibility study of the HighLife™ TMVR system.

Detailed description

This is an exploratory clinical study designed to evaluate the feasibility, safety and performance of the Highlife TMVR System in a population of patients with severe symptomatic mitral regurgitation, who are not suitable for surgical or approved percutaneous treatments according to the judgement of the Heart Team. The data gathered in this study will allow to evaluate the feasibility of mitral replacement using the HighLife™ TMVR system and characterize the safety and performance profile of the HighLife™ TMVR System. All patients will be followed periodically up to 12 months after the intervention and long term safety and performance will be collected annually up to 5 years.

Conditions

• Mitral Valve Regurgitation
• Mitral Valve Insufficiency

Interventions

Type	Name	Description
DEVICE	Transcatheter Mitral Valve Replacement	Minimally invasive transcatheter mitral valve implantation using the HighLife™ TMVR system

Timeline

• Start date: 2017-07-20
• Primary completion: 2018-11-18
• Completion: 2024-01-16
• First posted: 2016-11-29
• Last updated: 2024-10-03

Locations

10 sites across 2 countries: France, Germany