Targeted left ventricular lead placement in cardiac resynchronisation therapy

ISRCTN ISRCTN19717943
DOI https://doi.org/10.1186/ISRCTN19717943
Protocol serial number 1.0
Sponsor Papworth Hospital NHS Foundation Trust (UK)
Funder Biomedical Research Council (BMRC) (UK)
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

Level 6 ACCI Building
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Study information

Primary study designInterventional
Study designProspective randomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleTARgeted left ventricular lead placement to Guide cardiac rEsynchronisation Therapy in patients with heart failure: a randomised prospective study (TARGET Study)
Study acronymTARGET Study
Study objectivesThe 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) studiedCardiovascualr disease/heart failure/device therapy
InterventionAll 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 typeOther
Primary outcome measure(s)

Response to treatment defined as greater than 15% reduction in Left Ventricular End Systolic Volume at 6 months follow up

Key secondary outcome measure(s)

Clinical Improvement in combined endpoint of 6 minute walk test performance, Minnesota Living with Heart Failure Questionnaire and NYHA Class

Completion date01/10/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration220
Key inclusion criteria1. 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 criteria1. Limiting angina
2. Myocardial infarction within preceding 3 months
3. Significant LV hypertrophy
4. Severe co-morbid illness
Date of first enrolment01/04/2009
Date of final enrolment01/10/2011

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Level 6 ACCI Building
Cambridge
CB2 2QQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot 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
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
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