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

Обзор

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.

Вмешательства

• Процедура Optimised DeEP-guided ablation
  Optimised decrement evoked potential (DeEP) mapping in VT ablation.

Первичные конечные точки

• To determine acute success rate post Opto-DeEP mapping-guided VT ablation. [Срок оценки: From the start to the end of the VT ablation procedure.]

Критерии участия

Критерии включения

• ≥18 years old
• Patients with cardiac implantable electronic devices (CIED) (e.g. pacemakers, cardiac resynchronisation therapy (CRT) devices, implantable cardioverter defibrillator (ICD) devices)
• 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).
• Catheter ablation of VT ablation using Abbott intracardiac mapping catheter and Ensite intracardiac mapping system.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Великобритания · 1 центр

• University Hospitals Coventry & Warwickshire NHS Trust — Coventry

Идентификаторы

NCT: NCT06937983 · TD636723

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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