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Набор скоро начнётся NCT07573579

Dynamic Voltage Mapping to Personalise the Ventricular Tachycardia Substrate

Без фазы С лечением Ventricular Tachycardia (VT)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Dynamic Voltage Mapping, Standard of Care Ablation.
Кому может быть актуально
Состояния в реестре: Ventricular Tachycardia (VT). Базовые параметры: 18 лет — 85 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Великобритания
Следующий шаг
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Обзор

Ventricular tachycardia (VT) is a life-threatening heart rhythm disorder and one of the commonest causes of heart-related sudden death. It often affects people who have had a heart attack or other structural heart damage. VT occurs when abnormal electrical circuits develop within and around scar tissue in the heart. People at risk are usually offered an implantable cardiac defibrillator (ICD), a device that can detect VT and deliver a lifesaving shock. While effective, these shocks can be sudden, painful and distressing. Medications such as amiodarone can also help, but they are often unsuitable for long-term use due to their potential side effects on the liver, lungs and thyroid gland. An alternative is catheter ablation. Thin tubes (catheters) are threaded from a blood vessel in the groin to the heart, allowing the cardiologist to identify scar tissue and abnormal electrical circuits, which can be destroyed using heat, freezing or electrical energy. Although ablation can help many patients, VT can return in up to one in three people after the procedure. This is because it can be difficult to precisely identify the scar and surrounding tissue that sustain the abnormal circuits, making it challenging to know exactly where to apply ablation treatment. Dynamic Voltage Mapping, is a technique which the investigators believe can more accurately identify scar and the critical bordering tissue during ablation. Initial data collected suggests that the approach accurately predicts the VT circuit and helps guide ablation. In this study, the investigators wish to recruit 40 participants undergoing VT ablation to determine how effective Dynamic Voltage Mapping is in real-world procedures.

Вмешательства

  • Процедура Dynamic Voltage Mapping
    Dynamic Voltage Mapping uses electrical information collected from catheters positioned within the heart to create an individualised map of the heart, which the investigators hypothesise will better identify scar and surrounding tissue responsible for ventricular tachycardia.
  • Процедура Standard of Care Ablation
    Standard catheter ablation of ventricular tachycardia, guided by operator preference

Первичные конечные точки

  • Study Feasibility [Срок оценки: From enrolment to end of follow up (1 year after procedure)]
Вторичные конечные точки (4)
  • Procedural Time [Срок оценки: From start of procedure to end (skin-to-skin)]
  • Ablation time/number of lesions [Срок оценки: From start of procedure to end (skin-to-skin)]
  • Acute VT non-inducibility [Срок оценки: From start of procedure to end (skin-to-skin)]
  • VT recurrence Rate [Срок оценки: From end of procedure to end of follow up (12 months)]

Критерии участия

Критерии включения

  • Scheduled for clinically indicated VT ablation (due to sustained VT episodes or ICD therapies).
  • Willing and able to give informed consent for participation in the trial
  • Male or female aged between 18-85
  • Ischaemic and non-ischaemic cardiomyopathy
  • ICD insitu

Критерии исключения

  • Unable or unwilling to consent
  • NYHA Class IV (end stage heart failure)
  • Metastatic cancer
  • End stage renal disease
  • Pregnant or breast feeding
  • Severe frailty

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Великобритания · 1 центр
  • Liverpool Heart and Chest Hospital NHS Foundation Trust — Liverpool

Публикации

  • Grade Santos J, Mills MT, Calvert P, Worthington N, Phenton C, Modi S, Ashrafi R, Todd D, Waktare J, Mahida S, Gupta D, Luther V. Delineating postinfarct ventricular tachycardia substrate with dynamic voltage mapping in areas of omnipolar vector disarray. Heart Rhythm O2. 2024 Feb 27;5(4):224-233. doi: 10.1016/j.hroo.2024.02.006. eCollection 2024 Apr. PMID 38690145
  • Khanra D, Calvert P, Hughes S, Waktare J, Modi S, Hall M, Todd D, Mahida S, Gupta D, Luther V. An approach to help differentiate postinfarct scar from borderzone tissue using Ripple Mapping during ventricular tachycardia ablation. J Cardiovasc Electrophysiol. 2023 Mar;34(3):664-672. doi: 10.1111/jce.15766. Epub 2023 Jan 12. PMID 36478627
  • Mills MT, Calvert P, Chiong J, Gupta D, Luther V. Dynamic Voltage Mapping of the Post-infarct Ventricular Tachycardia Substrate: A Practical Technique to Help Differentiate Scar from Borderzone Tissue. Arrhythm Electrophysiol Rev. 2024 Oct 14;13:e16. doi: 10.15420/aer.2024.26. eCollection 2024. PMID 39507206

Идентификаторы

NCT: NCT07573579 · 35371 · FS/CRTF/25/24865

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗