Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve (TRANSFORM™)
The purpose of the clinical study is to prove that the heart valve device is safe, effective, and performs as intended.
Aortic Valve Stenosis
Aortic Valve Stenosis With Insufficiency
Regurgitation, Aortic Valve
Aortic Valve Incompetence
Device: EDWARDS INTUITY valve
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multi-CenTer Experience With the Rapid Deployment EDWARDS INTUITY Valve System FOR Aortic Valve ReplaceMent|
- Long term Performance: Clinically acceptable function by echocardiogram [ Time Frame: All subjects will be assessed for clinical follow-up at the following intervals: Discharge, 1 mo., 3 mo., 1 yr and annually thereafter thru 5 yr follow-up per subject. ] [ Designated as safety issue: Yes ]The safety endpoints consist of mortality, valve thrombosis, thromboembolism, hemorrhage, paravalvular leak, endocarditis, structural and non-structural valve deterioration, explant, hemolysis, re-operation, and implant related new or worsening of a cardiac conduction issue.
- Hemodynamic performance assessed by echocardiogram [ Time Frame: All subjects will be assessed for clinical follow-up at the following intervals: Discharge, 1 mo., 3 mo., 1 yr and annually thereafter thru 5 yr follow-up per subject. ] [ Designated as safety issue: No ]Effectiveness endpoints consists of device technical success, cross-clamp time, cardiopulmonary bypass time, length of time in the intensive care unit, NYHA functional class compared to baseline, and hemodynamic performance of the heart valve device confirmed by echocardiography.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||September 2018|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Experimental: EDWARDS INTUITY valve
All subjects enrolled into the study are implanted with the EDWARDS INTUITY Valve System.
Device: EDWARDS INTUITY valve
Surgical replacement of the aortic valve with the EDWARDS INTUITY valve.
This is a prospective, non-randomized, multi-center trial. Up to 950 subjects will be enrolled at up to 35 centers in the US. After re-placement of their aortic heart valve with the EDWARDS INTUITY valve system, each patient will have routine follow-up tests at the following intervals: discharge, 3 months, 1 year, and annually the-reafter for a minimum of five years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01700439
|Contact: Catherine Doorlyfirstname.lastname@example.org|
|Contact: Shawna Snodgrass, B.A, M.A.||email@example.com|
Show 27 Study Locations
|Principal Investigator:||Glenn Barnhart, MD||Swedish Medical Center|
|Principal Investigator:||Walter Randolph Chitwood, MD||East Carolina University|