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Using Non-Invasive Mapping To Eliminate Structural Heart Disease Ventricular Tachycardia: a UK Randomised Controlled Trial

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥18 years old

• Patient with the following:

‣ Evidence of post-myocardial infarction\* structural heart disease.

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

⁃ ICD/CRTD implantation.

⁃ Device therapy for VT: at least 1 appropriate ICD shock or 3 ATP episodes within a 6-month period.

• Suitable candidate for VT ablation as per NHS standard of care.

• Patient agrees to comply with study procedures and be available for routine follow up visits for at least 6 months after enrolment.

Locations
Other Locations
United Kingdom
Royal Sussex County Hospital
NOT_YET_RECRUITING
Brighton
University Hospitals Coventry and Warwickshire
RECRUITING
Coventry
The James Cook University Hospital
RECRUITING
Middlesbrough
Time Frame
Start Date: 2026-08-15
Estimated Completion Date: 2028-02-29
Participants
Target number of participants: 110
Treatments
Active_comparator: VIVO-assisted VT ablation
No_intervention: Standard VT Ablation
Sponsors
Collaborators: University Hospitals Coventry and Warwickshire NHS Trust
Leads: University of Warwick

This content was sourced from clinicaltrials.gov