NCT03813524

Cardiovalve Transfemoral Mitral Valve System

Early Feasibility Study of the Cardiovalve Transfemoral Mitral Valve System

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Boston Biomedical Associates · Academic / Other
• Sex: All
• Age: 18 Years – 84 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the safety and technical performance of the Cardiovalve Transfemoral Mitral Valve System with its associated procedure, to minimize 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 5 years.

Detailed description

The Cardiovalve offers a replacement valve delivered through a transfemoral access and transseptal approach, and is intended to reduce mortality and adverse event rates in selected patients for whom surgical options are not feasible. Innovation: A truly transfemoral, trans venous delivery of the valve which minimizes procedural risk. The Cardiovalve implant has a very low left ventricle (LV) protrusion footprint thus reducing the risk of LV outflow tract obstruction and/or interference with the LV. The experience to date is limited but thus far none of the clinical programs has been halted for safety reasons. Most of the technologies have focused on a transapical delivery approach (with mini-thoracotomy access) to further simplify the delivery method, with only a few allowing trans-septal delivery with femoral venous access.

Conditions

• Mitral Regurgitation

Interventions

Type	Name	Description
DEVICE	Cardiovalve Transfemoral Mitral Valve	The Cardiovalve Transfemoral Mitral Valve System is intended for use symptomatic patients with severe mitral regurgitation who are at elevated risk for surgical mitral valve repair or replacement and who are anatomically eligible for transfemoral mitral valve replacement with transseptal access to the left atrium.

Timeline

• Start date: 2019-03-26
• Primary completion: 2020-03-31
• Completion: 2020-03-31
• First posted: 2019-01-23
• Last updated: 2024-08-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study