NCT02711540

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 2, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

March 17, 2016

Status Verified

March 1, 2016

Enrollment Period

5 months

First QC Date

March 2, 2016

Last Update Submit

March 11, 2016

Conditions

Aortic Valve Stenosis

Outcome Measures

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

    30 days

Study Arms (2)

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

Balloon Aortic ValvuloplastyPROCEDURE

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

Pre-TAVI Balloon Aortic Valvuloplasty

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who had TAVI in the UK

You may qualify if:

  • Had TAVI procedure in UK

You may not qualify if:

  • Nil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Cardiologist

Study Record Dates

First Submitted

March 2, 2016

First Posted

March 17, 2016

Study Start

February 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

March 17, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share