SALUS Trial TranScatheter Aortic Valve RepLacement System Pivotal Trial The Safety and Effectiveness of the Direct Flow Medical Tanscatheter Aortic Valve System

Status: Unknown status
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable

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.

Participation Requirements
Sex: All
Healthy Volunteers: No

• The subject has severe senile degenerative aortic valve stenosis determined by echocardiogram and Doppler, or simultaneous pressure recordings at cardiac catheterization defined as: mean aortic gradient ≥40 mmHg, or an aortic valve area ≤1.0 cm2 or aortic valve area index ≤0.6 cm2/m2.

• The subject has moderate to severe symptoms from aortic valve stenosis (NYHA Functional Class ≥II).

• Subject has a documented aortic annulus size of ≥22 mm and <29 mm based on the center's assessment of pre-procedure diagnostic imaging (and confirmed by the Patient Review Committee [PRC]) and is deemed treatable with an available size of both test and control device.

• There is agreement by the heart team (which must include a site cardiac interventionalist and two cardiac surgeons which can be either two cardiac surgeon staff members at the hospital where the procedure is to be performed or one surgeon from the hospital where the procedure is to be performed and a surgeon from the referring institution or practice) that subject is at high operative risk or greater of serious morbidity or mortality with surgical valve replacement (see note below for definitions of extreme and high risk, the required level of surgical assessment, and PRC confirmation) and that TAVR is appropriate. Subjects will be designated either extreme risk (defined as a mortality or irreversible morbidity 50% or great at 30 days) or high risk (i.e., Society of Thoracic Surgeons operative risk score >8% or at a > 15% risk of surgical mortality at 30 days but not extreme risk). This conclusion shall be based on consensus of one cardiac interventionalist and two cardiac surgeons that have reviewed the case after careful consideration of the Subject's STS risk score and co-morbidities.

• Subject understands the study requirements and the treatment procedures, and provides written informed consent.

• Subject agrees and is capable of returning to the study hospital for all required scheduled follow up visits.

United States
New York
NewYork-Presbyterian / Columbia Univ.
New York
Ohio Health Riverside Methodist
University of Virginia Health System
Contact Information
Mary Edwards
Time Frame
Start Date: June 2015
Completion Date: December 2021
Target number of participants: 878
Experimental: Direct Flow Medical
Direct Flow Medical Transcatheter Aortic Valve Replacement System (TAVR)
Active Comparator: Commercially Available
Medtronic CoreValve Transcatheter Aortic Valve Replacement System (TAVR) or Edwards SAPIEN Transcatheter Aortic Valve Replacement System (TAVR)
Leads: Direct Flow Medical, Inc.

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