Ventricular tachycardia (VT) is an abnormal and dangerous heart rhythm affecting the lower chambers of the heart (the ventricles). Patients with structural heart disease caused by previous heart attacks are at an increased risk of developing VT. Current guidelines recommend that patients who develop this abnormal heart rhythm are considered for invasive catheter ablation (ICA). This is an invasive procedure where specialised catheters and a 3D electro anatomical mapping (EAM) system are used to identify the region of the heart responsible for the VT, which is then treated by tissue heating or freezing (ablation). Although significant improvements have been made in both mapping and ablation technologies, these procedures remain technically challenging and time consuming. View into ventricular onset (VIVO, Catheter Precision) is a non-invasive, mapping system already being used within the NHS. It uses images from previous heart scans, a picture of the patient's chest (taken at the start of the procedure) and a 12-lead electrocardiogram (ECG) tracing, to locate where the VT is coming from. The VIVO map can therefore highlight the likely region of interest for ICA prior to invasive EAM. This study will be a prospective, multi-centre, two-arm, non-blinded, randomised controlled trial (RCT). Patients will be evenly randomised (50:50) into a standard VT ablation group and a VIVO guided ablation group. In the VIVO guided ablation group, invasive EAM will be restricted to the region of interest identified using the VIVO map, rather than whole chamber mapping required for standard ablation. The primary objective will be to determine if the VIVO non-invasive mapping system reduces procedure duration and therefore improves workflow efficiency. Secondary objectives will assess the procedural success, safety and patient perceived health benefits of a VIVO guided ablation versus standard ablation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
110
VIVO (or View Into Ventricular Onset) is a non-invasive cardiac mapping technology which uses images from patients' previous heart scans, a picture of their chest (taken at the start of the procedure) and a tracing of their VT, to locate where the ventricular tachycardia is coming from.
Royal Sussex County Hospital
Brighton, United Kingdom
NOT_YET_RECRUITINGUniversity Hospitals Coventry and Warwickshire
Coventry, United Kingdom
RECRUITINGThe James Cook University Hospital
Middlesbrough, United Kingdom
RECRUITINGTotal procedural time (minutes)
the time from first incision (needle to skin) to the removal of the venous/arterial sheaths
Time frame: day of procedure
Procedure time in VT (minutes)
Time frame: during VT ablation procedure
Mapping time (minutes)
Time frame: during VT ablation procedure
Ablation time (minutes).
Time frame: During VT ablation procedure
Total number of ablation applications
Time frame: During ablation procedure
Total number of shocks delivered
Time frame: during the VT ablation procedure
Number of Participants with VT non-inducibility determined by Programmed Ventricular Stimulation (PVS)
Time frame: during VT ablation procedure
Number of Participants with substrate modification confirmed by remap
Time frame: during the VT ablation procedure
Total number of ICD/CRTD determined appropriate shock events
Total number of ICD/CRTD shock events per patient will be documented on database
Time frame: day of procedure to 6 months post-procedure
Total number of ICD/CRTD determined anti-tachycardia pacing (ATP) events
Total number of ICD/CRTD ATP events per patient will be documented on database
Time frame: day of procedure to 6 months post-procedure
Total number of VT episodes as determined from ICD/CRTD
Time frame: day of procedure to 6 months post-procedure
Recognised VT ablation procedural complications
Time frame: day of the procedure to 30 days after the VT ablation procedure
Total number of hospitalisations
Total number of hospitalisation events per patient will be documented on database
Time frame: day of the procedure to 30 days after the VT ablation procedure
Mortality
Time frame: day of the procedure to 30 days after the VT ablation procedure
Perceived health benefit of treatment
EQ-5D-5L
Time frame: at baseline and 6 months
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