Optimised Decrement Evoked Potential (DeEP) Mapping to Guide Ventricular Tachycardia (VT) Ablation in Patients With Structural Heart Disease VT (Opto-DeEP)

University Hospitals Coventry and Warwickshire NHS Trust

Status

Enrolling

Conditions

Structural Heart Disease

Treatments

Procedure: Optimised DeEP-guided ablation

Study type

Interventional

Funder types

Other

Identifiers

NCT06937983

TD636723

Details and patient eligibility

About

Ventricular tachycardia (VT) is a life-threatening heart rhythm disorder. Special pacemakers called implantable cardiac defibrillators (ICDs) help treat VT episodes, however they do not prevent the VT episodes from occurring. Catheter ablation for VT is a minimally-invasive and established procedure for preventing VT recurrence. This involves placing wires in the heart to find the diseased areas that are responsible for the VT episodes. The diseased areas are shown on computer-generated maps and are later removed via controlled tissue heating (ablation). A major challenge during the VT ablation procedure is locating the diseased area responsible for the VT episodes. Several methods have been described to locate the diseased heart area, however these methods are not always effective.

In this study, we aim to improve the identification of the diseased heart areas responsible for the VT episodes using a novel method. Our research group have developed, tested and peer-reviewed this improved method of locating diseased areas by looking for signals called decrementing evoked potentials (DeEPs). Ablation will target DeEPs shown on the computer-generated maps. We will assess if VT can be triggered at the end of the procedure. Patients will be monitored over 12 months to see if ablation of DeEPs leads to a reduction in VT episodes. We aim to recruit 77 patients with established heart disease of any cause, who have suffered VT episodes with ICDs. Suitable patients will be identified and recruited from inpatient and outpatient settings. A quality-of-life questionnaire will be completed by patients before and after the ablation procedure. The procedure will be performed as routine standard of care, in the cardiac catheter laboratory across multiple recruiting cardiac centres in the UK providing well established VT ablation service.

Overall, this study will contribute towards developing refined VT ablation techniques, aiming to improve patient outcomes.

Enrollment

77 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

≥18 years old
Patients with an implantable cardioverter defibrillator (ICD)
Eligible for VT ablation as part of standard care (urgent or elective)
Ischaemic heart disease and prior myocardial infarction (MI) (using the international definition of MI: Q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non-ischemic cause with documentation of prior ischaemic injury) OR other structural heart disease (such as: arrhythmogenic cardiomyopathy (ACM), or dilated cardiomyopathy (DCM), or hypertrophic cardiomyopathy (HCM), or sarcoidosis, or myocarditis).

Exclusion criteria

Lacks capacity to provide informed consent
New York Heart Association (NYHA) class IV heart failure
Life expectancy of less than 12 months
Implanted with a ventricular assist device
Presence of mobile intracardiac thrombus
Reversible cause of VT
Women who are pregnant or nursing
Both mechanical aortic and mitral valves
Enrolment in a concurrent interventional clinical study that in the judgement of the investigator would increase risk to the patient or deem the patient inappropriate to participate in this study.