NCT03958773

Cardiovalve Transfemoral System - FIM Study

Cardiovalve Transfemoral Mitral Valve System in Patients at High Surgical Risk With Severe Mitral Regurgitation

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Cardiovalve Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Cardiovalve system is a replacement valve delivered through a transfemoral access and transseptal approach and is intended for symptomatic patients with Mitral regurgitation for whom surgical options are not feasible.

Detailed description

The Cardiovalve system is a replacement valve delivered through a transfemoral access and transseptal approach and is intended for symptomatic patients with Mitral regurgitation for whom surgical options are not feasible. The purpose of this study is to evaluate the safety of the CardiovalveSystem with its associated procedure, and observe the device performance in reducing mitral regurgitation Data collected in this clinical study will include 30-day safety and performance of the device and delivery system, and long-term clinical outcomes over a follow-up of 2 years.

Conditions

• Mitral Regurgitation

Interventions

Type	Name	Description
DEVICE	Cardiovalve transfemoral Mitral valve system	Cardiovalve System, comprised of: 1) Cardiovalve Implant; 2) Cardiovalve Delivery System (DS); 3) Cardiovalve Accessories.

Timeline

• Start date: 2017-10-12
• Primary completion: 2026-10-30
• Completion: 2026-10-30
• First posted: 2019-05-22
• Last updated: 2026-01-05

Locations

1 site across 1 country: Lithuania