ACURATE TA™ Valve Implantation: SAVI Registry (Surveillance Plan #2011-02) (TA-SAVI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03143686|
Recruitment Status : Completed
First Posted : May 8, 2017
Last Update Posted : March 19, 2018
|Condition or disease||Intervention/treatment|
|Symptomatic Aortic Stenosis||Device: ACURATE TA™ Transapical Aortic Bioprosthesis|
|Study Type :||Observational|
|Actual Enrollment :||250 participants|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||November 2013|
ACURATE TA™ Transapical Aortic Bioprosthesis
The first two hundred and fifty (250) patients in whom the commercial, or CE Mark, ACURATE TATM Transapical Aortic Bioprosthesis is implanted.
Device: ACURATE TA™ Transapical Aortic Bioprosthesis
ACURATE TA™ Transapical Aortic Bioprosthesis is intended for subjects with severe symptomatic aortic stenosis and are considered high risk for surgical conventional Aortic Valve Replacement.
Other Name: ACURATE TA™ Transapical Aortic Bioprosthesis and delivery System
- Rate of major cardiac and cerebrovascular event (MACCE) at 30 days and at 12 months post-implant [ Time Frame: 30 days and 12 Months Follow-up ]
Rate of major cardiac and cerebrovascular event (MACCE) at 30 days and at 12 months post-implant .
MACCE defined as All cause mortality, Re-intervention, Myocardial Infarction, or Stroke.
- Procedural Success post-implantation (up to 24 hours after device implantation) [ Time Frame: Post-Implantation (up to 24 hours after device implantation) ]Procedural success defined as successful ACURATE TA™ implantation at intended site and adequate device functioning immediately post-implantation and without intra-procedural mortality
- Device success at 30 days and 12 Months follow-up [ Time Frame: 30 days and 12 Months follow-up ]Device success at 30 day and 12 month follow-up visit defined as adequate functioning of the ACURATE TA™ as confirmed by echocardiography.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03143686