NCT03714412

Feasibility Study of Patients With Severe MR Treated With the Cardiovalve TMVR System

Feasibility Study of High Surgical Risk Patients With Severe Mitral Regurgitation Treated With the Cardiovalve Transfemoral Mitral Valve System

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Cardiovalve Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will test the safety and performance of the Cardiovalve transfemoral mitral valve replacement system in treating patients with severe mitral regurgitation who are at high risk for open chest surgery. The system is comprised of comprised of: 1) an Implant; 2) a Delivery System (DS); and 3) Accessories that are required for the implantation procedure. the procedure is performed under general anesthesia.

Detailed description

The study will test the safety and performance of the Cardiovalve transfemoral mitral valve replacement system in treating patients with severe mitral regurgitation who are at high risk for open chest surgery. The system is comprised of comprised of: 1) an Implant; 2) a Delivery System (DS); and 3) Accessories that are required for the implantation procedure. The implant procedure is performed under general anesthesia, and the participants will be followed-up at discharge, 1- 3-, 6-, 12- and 24-months post-procedure, in order to check the system functionality and effect on their cardiology status.

Conditions

• Mitral Regurgitation

Interventions

Type	Name	Description
DEVICE	Implantation	Implantation of the Cardiovalve transfemoral mitral valve replacement system

Timeline

• Start date: 2019-09-01
• Primary completion: 2019-12-15
• Completion: 2023-12-15
• First posted: 2018-10-22
• Last updated: 2019-05-01

Locations

2 sites across 2 countries: Greece, Poland