Brief Title
Retrospective Analysis of Procedural Aspects of Transcatheter Aortic Valve Implantation (TAVI) on Peri-procedural Stroke
Official Title
Retrospective Analysis of Procedural Aspects of Transcatheter Aortic Valve Implantation (TAVI) on Peri-procedural Stroke Rates in the United Kingdom
Brief Summary
Retrospective analysis of all patients receiving TAVI in the United Kingdom (UK). Stroke rates following TAVI are roughly 3%. There are several device and procedure related characteristics which may increase the risk of stroke. We will examine if there is a signal in the UK registry. This will be important is TAVI is to be extended down to lower risk patient cohorts.
Detailed Description
Retrospective analysis of all patients receiving TAVI in the UK. Stroke rates following TAVI are roughly 3%. There are several device and procedure related characteristics which may increase the risk of stroke. We will examine if there is a signal in the UK registry. This will be important is TAVI is to be extended down to lower risk patient cohorts. Factors to be examined include (but not limited to): need for Pre-procedure Balloon aortic Valvuloplasty (BAV) Need for two valves need for post-dilatation need for rapid ventricular burst pacing
Study Type
Observational
Primary Outcome
Stroke
Condition
Aortic Valve Stenosis
Intervention
Balloon Aortic Valvuloplasty
Study Arms / Comparison Groups
Pre-TAVI Balloon Aortic Valvuloplasty
Description: This is the cohort of patients in the study who did receive Balloon Aortic Valvuloplasty (BAV) prior to TAVI implantation
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
4000
Start Date
February 2016
Completion Date
July 2016
Primary Completion Date
July 2016
Eligibility Criteria
Inclusion Criteria: - Had TAVI procedure in UK Exclusion Criteria: - Nil
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Administrative Informations
NCT ID
NCT02711540
Organization ID
TAVIStrokePredictors
Responsible Party
Principal Investigator
Study Sponsor
Royal Sussex County Hospital
Study Sponsor
, ,
Verification Date
March 2016