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Transcatheter Aortic Valve Replacement System Pivotal Trial

NCT02163850 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 878

Last updated 2016-05-03

No results posted yet for this study

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.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

Direct Flow Medical

Direct Flow Medical Transcatheter Aortic Valve Replacement System (TAVR)

DEVICE

Commercially Available

Medtronic CoreValve Transcatheter Aortic Valve Replacement System (TAVR) or Edwards SAPIEN Transcatheter Aortic Valve Replacement System (TAVR)

Sponsors & Collaborators

  • Direct Flow Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Scott Lim, M.D. · Associate Professor of Pediatrics and Medicine and Director of Advanced Cardiac Valve Center at University of Virginia

  • Isacc George · Columbia University, Assitant Professor of Surgery Division of Cadiothoracic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2017-12-31
Completion
2021-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02163850 on ClinicalTrials.gov