Targeted left ventricular lead placement in cardiac resynchronisation therapy
| ISRCTN | ISRCTN19717943 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19717943 |
| Secondary identifying numbers | 1.0 |
- Submission date
- 01/09/2010
- Registration date
- 08/02/2011
- Last edited
- 19/06/2012
- 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 David Dutka
Scientific
Scientific
Level 6 ACCI Building
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom
Study information
| Study design | Prospective randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a patient information sheet |
| Scientific title | TARgeted left ventricular lead placement to Guide cardiac rEsynchronisation Therapy in patients with heart failure: a randomised prospective study (TARGET Study) |
| Study acronym | TARGET Study |
| Study objectives | The clinical response to cardiac resynchronisation therapy will be improved by optimising the site of left ventricular (LV) pacing using a targeted approach to optimal sites defined by pre-implant speckle tracking 2D radial strain as the latest contracting segments. |
| Ethics approval(s) | Hertfordshire Research Ethics Committee approved on the 14th October 2008 (ref: 08/H0311/133) |
| Health condition(s) or problem(s) studied | Cardiovascualr disease/heart failure/device therapy |
| Intervention | All patients schedules for CRT who are suitable candidates are randomised into one of two groups. All patients have baseline tests to include echocardiography, NYHA class assessment, 6-minute walk test, QoL score and speckle training echocardiography (STE). At implant, the control group has a usual implant and the target group has the devide implanted using echo guidance. All patients are followed up again at 6 months with a repeat of the baseline tests. |
| Intervention type | Other |
| Primary outcome measure | Response to treatment defined as greater than 15% reduction in Left Ventricular End Systolic Volume at 6 months follow up |
| Secondary outcome measures | Clinical Improvement in combined endpoint of 6 minute walk test performance, Minnesota Living with Heart Failure Questionnaire and NYHA Class |
| Overall study start date | 01/04/2009 |
| Completion date | 01/10/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 220 (110 in each arm) |
| Key inclusion criteria | 1. Patients (aged 18 years or older, either sex) limited by symptoms of heart failure (New York Heart Association Class III - IV) 2. Left ventricular ejection fraction (LVEF) of less than or equal to 35% and QRS width of greater than or equal to 120 ms despite maximally tolerated doses of standard heart failure treatment (diuretics, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers, beta blockers and aldosterone antagonists) |
| Key exclusion criteria | 1. Limiting angina 2. Myocardial infarction within preceding 3 months 3. Significant LV hypertrophy 4. Severe co-morbid illness |
| Date of first enrolment | 01/04/2009 |
| Date of final enrolment | 01/10/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Level 6 ACCI Building
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Sponsor information
Papworth Hospital NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
R&D Department
Papworth Hospital
Cambridge
CB23 8RE
England
United Kingdom
| Website | http://www.papworthhospital.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/01qbebb31 |
Funders
Funder type
Research council
Biomedical Research Council (BMRC) (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 | 24/04/2012 | Yes | No |
