Using Non-Invasive Mapping To Eliminate Structural Heart Disease Ventricular Tachycardia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Warwick

About this trial

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.

Eligibility criteria

Qualifiers

≥18 years old

Evidence of post-myocardial infarction* structural heart disease.

Cardiac CT and/or cardiac MRI scan performed within 6 months.

ICD/CRTD implantation.

Disqualifiers

Lacks capacity to provide informed consent.

Presence of intramural thrombus, tumour or abnormality that precludes vascular access, catheter introduction or manipulations.

Coagulopathy, bleeding diathesis or suspected pro-coagulant state.

Sepsis, active systemic infection or fever (>100.5 F/38 C) within a week prior to the ablation procedure.

Trial design

Treatments tested in this trial

  • VIVO-assisted mapping

Treatment groups

110 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Warwick

Lead sponsor

University Hospitals Coventry and Warwickshire NHS Trust

Collaborator