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NCT02711540 Clinical Trial

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

Aortic Valve Stenosis Clinical Trial

Official title:
Retrospective Analysis of Procedural Aspects of Transcatheter Aortic Valve Implantation (TAVI) on Peri-procedural Stroke Rates in the United Kingdom

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02711540
Other study ID # TAVIStrokePredictors
Secondary ID
Status Active, not recruiting
Phase N/A
First received March 2, 2016
Last updated March 11, 2016
Start date February 2016
Est. completion date July 2016

Study information
Verified date March 2016
Source Royal Sussex County Hospital
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Observational

Clinical Trial 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.

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 4000
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Had TAVI procedure in UK

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Balloon Aortic Valvuloplasty
Some patients receive BAV prior to TAVI implantation to facilitate better deployment of the TAVI valve

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Royal Sussex County Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Stroke 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 30 days No
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