Condition category
Circulatory System
Date applied
13/04/2010
Date assigned
18/06/2010
Last edited
27/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stephen Brecker

ORCID ID

Contact details

St. George’s Hospital
Blackshaw Road
London
SW17 0QT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.1

Study information

Scientific title

New Transcatheter Aortic Valve Implantation (TAVI) Guidewire: a prospective first-in-man single-centre open-label non-randomised feasibility study

Acronym

TAVI Guidewire

Study hypothesis

New guidewire design successfully delivers a transcatheter aortic valve (TAV).

Ethics approval

Ealing and West London Research Ethics Committee, 31/03/2010, ref: 10/H0710/4

Study design

Prospective single-centre open-label non-randomised feasibility study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Aortic stenosis, cardiovascular disease

Intervention

All consenting patients will be allocated to the normal standard of treatment for TAV implantation including the follow-up. The only difference is the used of the new guidewire during implantation.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Technical success of the TAVI procedure, measured at end of procedure

Secondary outcome measures

Guidewire performance, measured at end of procedure

Overall trial start date

01/06/2010

Overall trial end date

31/05/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients scheduled for transcatheter aortic valve implantation (TAVI)
2. Male and female, aged 18 - 100 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/06/2010

Recruitment end date

31/05/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St. George’s Hospital
London
SW17 0QT
United Kingdom

Sponsor information

Organisation

St George's, University of London (UK)

Sponsor details

c/o Ira Jakupovic
Joint Research Office
Ground Floor
Hunter Wing
Cranmer Terrace
London
SW17 0RE
United Kingdom

Sponsor type

University/education

Website

http://www.sgul.ac.uk/

Funders

Funder type

Government

Funder name

NHS Innovations London (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23339807

Publication citations

  1. Results

    Roy DA, Laborde JC, Sharma R, Jahangiri M, Brecker SJ, First-in-man assessment of a dedicated guidewire for transcatheter aortic valve implantation., EuroIntervention, 2013, 8, 9, 1019-1025, doi: 10.4244/EIJV8I9A157.

Additional files

Editorial Notes