Retrospective Analysis of Procedural Aspects of Transcatheter Aortic Valve Implantation (TAVI) on Peri-procedural Stroke

• Conditions: Aortic Valve Stenosis
• Interventions: Procedure: Balloon Aortic Valvuloplasty

• Registration Number: NCT02711540
• Lead Sponsor: Royal Sussex County Hospital

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 Timeline

• Study Start: 2016-02
• Status Verified: 2016-03
• Study First Submitted: 2016-03-02
• Study First Submitted QC: 2016-03-11
• Last Update Submitted: 2016-03-11
• Study First Posted: 2016-03-17
• Last Update Posted: 2016-03-17
• Primary Completion: 2016-07
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

• Had TAVI procedure in UK

Exclusion Criteria

• Nil

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pre-TAVI Balloon Aortic Valvuloplasty	Balloon Aortic Valvuloplasty	This is the cohort of patients in the study who did receive Balloon Aortic Valvuloplasty (BAV) prior to TAVI implantation

Primary Outcome Measures

Name	Time	Method
Stroke	30 days	Stroke, defined as new neurological deficit with corresponding change on CT scan of brain, is a self reported event following TAVI. All centres performing TAVI in the United Kingdom are required to report this to the National Institute for Cardiovascular Outcomes Research (NICOR) registry which is being analysed in this study