Overview

This trial is active, not recruiting.

Condition aortic valve stenosis
Treatment balloon aortic valvuloplasty
Sponsor Royal Sussex County Hospital
Start date February 2016
End date July 2016
Trial size 4000 participants
Trial identifier NCT02711540, TAVIStrokePredictors

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
This is the cohort of patients in the study who did receive Balloon Aortic Valvuloplasty (BAV) prior to TAVI implantation
balloon aortic valvuloplasty
Some patients receive BAV prior to TAVI implantation to facilitate better deployment of the TAVI valve
This is the cohort of patients in the study who did not receive Balloon Aortic Valvuloplasty (BAV) prior to TAVI implantation

Primary Outcomes

Measure
Stroke
time frame: 30 days

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Had TAVI procedure in UK Exclusion Criteria:

Additional Information

Official title Retrospective Analysis of Procedural Aspects of Transcatheter Aortic Valve Implantation (TAVI) on Peri-procedural Stroke Rates in the United Kingdom
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
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Royal Sussex County Hospital.