New Transcatheter Aortic Valve Implantation (TAVI) Guidewire
| ISRCTN | ISRCTN29111908 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29111908 |
| Protocol serial number | 1.1 |
| Sponsor | St George's, University of London (UK) |
| Funder | NHS Innovations London (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Prospective single-centre open-label non-randomised feasibility study |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant 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(s) |
Technical success of the TAVI procedure, measured at end of procedure |
| Key secondary outcome measure(s) |
Guidewire performance, measured at end of procedure |
| Completion date | 31/05/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
St. Georges Hospital
London
SW17 0QT
United Kingdom
SW17 0QT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
