Transcatheter Aortic Valve Replacement System Pivotal Trial

Not Applicable

• Conditions: Aortic Valve Stenosis
• Interventions: Device: Commercially Available; Device: Direct Flow Medical

• Registration Number: NCT02163850
• Lead Sponsor: Direct Flow Medical, Inc.

Brief Summary

Prospective, randomized, unblinded, multi-center investigational study with enrollment at up to 45 investigational sites. The study is designed to compare the study device (Direct Flow Medical Transcatheter Aortic Valve System) composite event rate to a blended commercial comparator (using approved Medtronic self-expanding bioprosthesis or Edwards balloon-expandable bioprosthesis) in high and extreme risk Subjects with severe symptomatic aortic stenosis. Subjects will be followed through the index procedure, hospital discharge, and at 30 days, 6 months and 1 year for the primary endpoint analysis. Thereafter, annual follow-up at 2 through 5 years will be conducted and analyzed separately.

Detailed Description

Prospective, randomized, unblinded, multi-center investigational study with enrollment at up to 45 investigational sites. The study is designed to compare the study device (Direct Flow Medical Transcatheter Aortic Valve System) composite event rate to a blended commercial comparator (using approved Medtronic self-expanding bioprosthesis or Edwards balloon-expandable bioprosthesis) in high and extreme risk Subjects with severe symptomatic aortic stenosis. Subjects will be followed through the index procedure, hospital discharge, and at 30 days, 6 months and 1 year for the primary endpoint analysis. Thereafter, annual follow-up at 2 through 5 years will be conducted and analyzed separately.

The primary study endpoint is a composite of all-cause mortality, disabling stroke, or moderate or greater residual aortic regurgitation (based on core lab assessment) at 1 year. All primary endpoint events will be evaluated by a CEC using the definitions located in this protocol.

A sample size of 648 subjects (432 subjects in Direct Flow Medical Transcatheter Aortic Valve System cohort + 216 subjects in blended control cohort) will provide at least 85% power to test that the study device is non-inferior to the comparator with non-inferiority margin of 10%.

Subjects must meet the fundamental enrollment criteria of severe symptomatic, calcific aortic stenosis with quantifiable and documented source records.

Study Timeline

• Study First Submitted: 2014-06-10
• Study First Submitted QC: 2014-06-12
• Study First Posted: 2014-06-16
• Study Start: 2015-06
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-29
• Last Update Posted: 2016-05-03
• Primary Completion: 2017-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 878

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Commercially Available	Commercially Available	Medtronic CoreValve Transcatheter Aortic Valve Replacement System (TAVR) or Edwards SAPIEN Transcatheter Aortic Valve Replacement System (TAVR)
Direct Flow Medical	Direct Flow Medical	Direct Flow Medical Transcatheter Aortic Valve Replacement System (TAVR)

Primary Outcome Measures

Name	Time	Method
Death (all cause) and disabling stroke.	12 Months	The primary study endpoint is a composite of all-cause mortality, disabling stroke, or moderate or greater residual aortic regurgitation (based on core lab assessment) at 1 year.

Trial Locations

Locations (3)

NewYork-Presbyterian / Columbia Univ.; 🇺🇸 New York, New York, United States

Ohio Health Riverside Methodist; 🇺🇸 Columbus, Ohio, United States

University of Virginia Health System; 🇺🇸 Charlottesville, Virginia, United States