CClinicalTrials.gg
Status unknownNCT02711540Updated Mar 17, 2016

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

An observational study in Aortic Valve Stenosis, sponsored by Royal Sussex County Hospital. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-17.

Sponsored by Royal Sussex County Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2016), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
4,000
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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

02

Conditions studied

  • Aortic Valve Stenosis

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03

In context

Aortic Valve Stenosis

985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.

This study's enrollment of 4,000 is above the median of 200 across 424 observational studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

Royal Sussex County Hospital is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients who had TAVI in the UK

Inclusion criteria

  • Had TAVI procedure in UK

Exclusion criteria

Exclusion Criteria:

  • Nil
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
4,000 participants (actual)
Patient registry
No

Groups and cohorts

  • Pre-TAVI Balloon Aortic Valvuloplasty

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

    Procedure: Balloon Aortic Valvuloplasty

  • No Pre-TAVI Balloon Aortic Valvuloplasty

    This is the cohort of patients in the study who did not receive Balloon Aortic Valvuloplasty (BAV) prior to TAVI implantation

Interventions

  • ProcedureBalloon Aortic Valvuloplasty

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

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 30 days

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02711540
Lead sponsor
Royal Sussex County Hospital
Responsible party
David Hildick-Smith (Consultant Cardiologist, Royal Sussex County Hospital) — Principal investigator
First posted
Mar 17, 2016
Start date
Feb 2016
Primary completion
Jul 2016 (estimated)
Completion
Jul 2016 (estimated)
Last update
Mar 17, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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