NCT03893578

The Conveyor Study

First in Human Safety Study of the Synecor Conveyor System Used for Delivery of a Minimally Invasive Mitral Valve

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Synecor, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate that the Conveyor System can safely provide left ventricular access to deliver the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve in patients who have been diagnosed with prior mitral valve replacement or repair (failing bioprosthetic mitral valve) who are candidates for mitral valve-in-valve procedure.

Detailed description

This is a prospective, non-randomized, multi-center early feasibility study designed to demonstrate that the Conveyor System can safely provide left ventricular access to deliver an Edwards SAPIEN 3 TAVR valve into the mitral valve position in a valve-in-valve procedure. This study will enroll patients with symptomatic heart disease due to a failing bioprosthetic mitral valve (stenosed insufficient, or combined).

Conditions

• Mitral Valve Insufficiency
• Mitral Valve Disease
• Mitral Valve Regurgitation
• Heart Failure

Interventions

Type	Name	Description
DEVICE	Mitral valve-in-valve	The Synecor Conveyor System shall be used to position the Edwards SAPIEN 3 valve at the mitral location.

Timeline

• Start date: 2019-04-01
• Primary completion: 2019-12-01
• Completion: 2020-02-01
• First posted: 2019-03-28
• Last updated: 2019-04-05

Regulatory

• FDA-regulated device study