New Transcatheter Aortic Valve Implantation (TAVI) Guidewire
| ISRCTN | ISRCTN29111908 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29111908 |
| Secondary identifying numbers | 1.1 |
- Submission date
- 13/04/2010
- Registration date
- 18/06/2010
- Last edited
- 27/08/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Stephen Brecker
Scientific
Scientific
St. Georges Hospital
Blackshaw Road
London
SW17 0QT
United Kingdom
Study information
| Study design | Prospective single-centre open-label non-randomised feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | New Transcatheter Aortic Valve Implantation (TAVI) Guidewire: a prospective first-in-man single-centre open-label non-randomised feasibility study |
| Study acronym | TAVI Guidewire |
| Study objectives | New guidewire design successfully delivers a transcatheter aortic valve (TAV). |
| Ethics approval(s) | Ealing and West London Research Ethics Committee, 31/03/2010, ref: 10/H0710/4 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Technical success of the TAVI procedure, measured at end of procedure |
| Secondary outcome measures | Guidewire performance, measured at end of procedure |
| Overall study start date | 01/06/2010 |
| Completion date | 31/05/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20 |
| Key inclusion criteria | 1. Patients scheduled for transcatheter aortic valve implantation (TAVI) 2. Male and female, aged 18 - 100 years |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/06/2010 |
| Date of final enrolment | 31/05/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
St. Georges Hospital
London
SW17 0QT
United Kingdom
SW17 0QT
United Kingdom
Sponsor information
St George's, University of London (UK)
University/education
University/education
c/o Ira Jakupovic
Joint Research Office
Ground Floor, Hunter Wing
Cranmer Terrace
London
SW17 0RE
England
United Kingdom
| Website | http://www.sgul.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/040f08y74 |
Funders
Funder type
Government
NHS Innovations London (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 22/01/2013 | Yes | No |
