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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02711540

Enrollment

4000

Registered

2016-03-17

Start date

2016-02-29

Completion date

2016-07-31

Last updated

2016-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis

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

Interventions

PROCEDUREBalloon Aortic Valvuloplasty

Some patients receive BAV prior to TAVI implantation to facilitate better deployment of the TAVI valve

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Had TAVI procedure in UK

Exclusion criteria

* Nil

Design outcomes

Primary

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026