Clinical Trial: Percutaneous Aortic Valve 18F System for the Treatment of Patients With Severe Aortic Stenosis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Evaluation of the Direct Flow Medical Percutaneous Aortic Valve 18F System for the Treatment of Patients With Severe Aortic Stenosis

Brief Summary: The purpose of the study is to determine the safety and performance of the Direct Flow Medical study valve and delivery procedure.

Detailed Summary: Prospective, multicenter, non-randomized clinical trial of the Direct Flow Medical Percutaneous Aortic Valve 18F System for the treatment of severe aortic stenosis
Sponsor: Direct Flow Medical, Inc.

Current Primary Outcome: Freedom from all-cause mortality from procedure to 30 days [ Time Frame: Procedure to 30 days ]

Original Primary Outcome:

Current Secondary Outcome: Device Success at procedure completion [ Time Frame: At procedure completion ]

Device success is assessed at the completion of the study procedure based on TEE


Original Secondary Outcome:

Information By: Direct Flow Medical, Inc.

Dates:
Date Received: November 17, 2011
Date Started: November 2011
Date Completion: July 2019
Last Updated: October 31, 2016
Last Verified: October 2016