Radiotherapy vs Catheter Ablation for Ventricular Tachycardia in Structural Heart Disease

Обзор

The goal of this randomized clinical trial is to test the efficacy of stereotactic body radiation therapy (SBRT) in treating ventricular tachycardia (VT) in patients with advanced structural heart disease. The main questions it aims to answer are: * What is the efficacy of SBRT compared to catheter ablation (CA) in achieving a ≥ 75% reduction in VT burden at 6 months * What is the comparable safety profile of SBRT vs CA Researchers will compare SBRT and CA (standard of care).

Подробное описание

Hypothesis

We hypothesise that in an open label randomised controlled trial of patients with advanced structural heart disease and ventricular tachycardia (VT) that stereotactic body radiation therapy (SBRT) will be superior in reducing VT burden compared to standard care comprising of catheter ablation (CA) and routine medical care with acceptable safety and adverse events.

Aims

This is a trial to examine if in an open label randomised trial of 60 patients with structural heart disease and VT followed for 3 years with a minimum follow up of 1 year of SBRT compared CA results in:

1. An improvement in a primary outcome of proportion of patients with a ≥75% reduction in VT burden in the 6 months following intervention compared to the 6 months intervention 2. Comparable safety profile (serious adverse events \[SAE\] and adverse events of special interest \[AESI\] at 6 months; 3. reduction in secondary endpoints at 6, 12, 24 and 36 months of: any VT recurrence, absolute % reduction in VT burden compared to 6 months pre-treatment, number of anti-arrhythmic drugs (AADs) compared to pre-treatment, cardiovascular hospitalisation, all-cause mortality, cardiac transplantation, combined endpoint of cardiovascular hospitalisation/transplant/mortality, SAE and AESI from treatment, ventricular function abd change of quality of life (QOL) metrics (at 12 months).

Вмешательства

• Лучевая терапия SBRT
  Delivery of 25Gy in a single dose fraction to target area within 6 weeks of randomization
• Процедура CA
  CA (endocardial and/or epicardial at operator discretion) within 6 weeks of randomization.

Первичные конечные точки

• VT burden [Срок оценки: 6 months]

Вторичные конечные точки (12)

• Recurrent sustained VT [Срок оценки: 6, 12, 24 and 36 months]
• VT storm [Срок оценки: 6, 12, 24 and 36 months]
• Absolute VT burden [Срок оценки: 6, 12, 24 and 36 months]
• Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESI) [Срок оценки: At all time points up to 36 months]
• ICD shocks [Срок оценки: 6, 12, 24 and 36 months]
• Hospitalization [Срок оценки: 6, 12, 24 and 36 months]
• All cause mortality [Срок оценки: 6,12, 24 and 36 months]
• Cardiovascular Mortality [Срок оценки: 6,12, 24 and 36 months]
• Composite outcome of VT recurrence/hospitalisation/death/ cardiac transplantation [Срок оценки: 6,12, 24 and 36 months]
• Ventricular function [Срок оценки: 6,12, 24 and 36 months]
• Quality of Life as per Short Form - 36 (SF-36) Score [Срок оценки: 6,12, 24 and 36 months]
• Quality of Life as per Implantable Cardioverter Defibrillator Concerns Questionnaire (ICDC) score [Срок оценки: 6,12, 24 and 36 months]

Критерии участия

Критерии включения

• Structural heart disease (including ischaemic cardiomyopathy , non-ischaemic cardiomyopathy or congenital heart disease and defined as any one of

• segmental or global decreased ventricular wall motion as defined by TTE, CT or cMRI
• myocardial hypertrophy
• myocardial scar (evidenced by late gadolinium enhancement on cMRI, wall thinning on cardiac CT, low voltage on electrophysiological study or abnormal intracardiac echocardiography)
• Recurrent monomorphic VT which can include

• at least one episode of VT treated by ICD and/or
• sustained VT (lasting >30s) and/or
• inducible sustained VT on invasive electrophysiological study (EPS) or non-invasive programmed stimulation (NIPS)
• PAINESD score of ≥9 points and/or at least moderate risk of VT recurrence or death as defined by the I-VT score. Both are validated tools used clinically to identify patient at high risk of VT recurrence and/or mortality after CA.

Критерии исключения

• Age < 18 years
• Life expectancy < 3 months
• Catheter ablation deemed futile or with prohibitive risk by cardiac electrophysiologist.
• Unwilling or unable to provide consent
• Known cardiac channelopathies (e.g. Catecholaminergic polymorphic ventricular tachycardia (CPVT), long- or short QT syndrome, Brugada syndrome)
• Contraindications to radiotherapy as deemed by referring physician and/or radiation oncologist
• Pregnancy or breast feeding

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

Простое слепое

Основная цель

Лечение

Центры проведения

Австралия · 1 центр

• Westmead Hospital — Westmead

Идентификаторы

NCT: NCT06360939 · ETH02659

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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