Идёт набор NCT06743789

Trial in Arrhythmia Radioablation for Ventricular Tachycardia: Single Fraction vs Three Fractions

Без фазы С лечением Ventricular Tachycardia

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: Radiation Therapy, Radiation Therapy, Radiation Therapy, Radiation Therapy.
Кому может быть актуально: Состояния в реестре: Ventricular Tachycardia. Базовые параметры: 18 лет — 90 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: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Dose De-escalation Randomized Phase I/II Trial in Arrhythmia Radioablation for Ventricular Tachycardia: Single Fraction vs Three Fractions

Обзор

This is a research study that aims to understand if giving a lower dose of treatment all at once is as effective and safe as dividing it into three smaller doses for patients with a heart condition called refractory ventricular tachycardia (VT). These patients have not exhibited positive responses to conventional medications or procedures. This study aims to explore whether an alternative approach could yield more beneficial outcomes.

Подробное описание

Ventricular tachycardia (VT) is a life-threatening heart rhythm disorder that arises from areas of diseased tissue in the heart. Treatment of VT can involve anti-arrhythmic drugs and catheter-based ablations. Unfortunately, despite multiple antiarrhythmic drugs, as well as the catheter-based ablation procedures, VT continues to persist in your case. At this point in time, The investigators believe that stereotactic body radiotherapy (SBRT) remains the only possible option to potentially treat VT. The investigators hypothesize that by administering SBRT at different dose levels and fractionation may achieve a better therapeutic ratio, defined as comparable efficacy with less risk of toxicity due to lower dose exposure to the normal tissue, including the heart vasculature, in patients when compared to VT patients who receive a dose of 25Gy in a single fraction which is the current treatment option.

This is a randomized dose de-escalation trial where the patients will be randomized in in one of the two experimental arms, receiving 1 single fraction OR 3 daily consecutive fractions of RT, and will be treated into a prespecified dose level group, based on the study development. The study includes three de-escalated consecutive dose level groups for each of two randomized treatment arms and there will be 3 patients per group and each group will receive a particular radiation treatment either as single treatments or three treatments.

The purpose of this treatment is to safely reduce episodes of VT.

Вмешательства

Лучевая терапия Radiation Therapy
Group 1 (3 participants) - will receive a dose of 20 Gy ("Gray", a measurement of radiation) in a single study intervention (one study intervention day)
Лучевая терапия Radiation Therapy
Group 2 (3 participants) - will receive a dose of 15 Gy in a single study intervention (one study intervention day)
Лучевая терапия Radiation Therapy
Group 3 (3 participants) - will receive a dose of 10 Gy in a single study intervention (one study intervention day)
Лучевая терапия Radiation Therapy
Group 1 (3 participants) - will receive a dose of 12 Gy given over 3 days (Days 1, 2 and 3). (Total radiation dose = 36Gy)
Лучевая терапия Radiation Therapy
Group 2 (3 participants) - will receive a dose of 10 Gy given over 3 days (Days 1, 2 and 3). (Total radiation dose = 30Gy)
Лучевая терапия Radiation Therapy
Group 3 (3 participants) - will receive a dose of 8 Gy given over 3 days (Days 1, 2 and 3). (Total radiation dose = 24Gy)

Первичные конечные точки

Efficacy as measured by number of subjects with a reduction ≥ 60% (tracked by ICD recordings) ventricular tachycardia (VT) episodes [Срок оценки: 6 months before treatment]
Efficacy as measured by number of subjects with a reduction ≥ 60% (tracked by ICD recordings) ventricular tachycardia (VT) episodes [Срок оценки: 6 weeks post treatment]
Number of treatment-related serious adverse events (SAEs) [Срок оценки: 6 weeks post treatment]

Вторичные конечные точки (12)

Number of ventricular tachycardia (VT) episodes [Срок оценки: 3 months post]
Number of ventricular tachycardia (VT) episodes [Срок оценки: 6 months post]
Number of ventricular tachycardia (VT) episodes [Срок оценки: 12 months]
Number of subacute treatment side-effects [Срок оценки: 3 months post]
Number of subacute treatment side-effects [Срок оценки: 6 months post]
Number of late Adverse events [Срок оценки: 1 year post]
Number of late Adverse events [Срок оценки: 2 year post]
Overall survival [Срок оценки: 1 year post]
Overall survival [Срок оценки: 2 year post]
Recurrence free survival [Срок оценки: 3 months post]
Recurrence free survival [Срок оценки: 6 months post]
Recurrence free survival [Срок оценки: 12 months post]

Критерии участия

Критерии включения

Age ≥ 18 years
Structural heart disease:

Ischemic cardiomyopathy
Non-ischemic cardiomyopathy
Hypertrophic cardiomyopathy
Refractory VT severity:

VT leading to ICD shock with minimum 3 episodes in any 3-month period without reversible cause;
Failed or intolerant to antiarrhythmic drug therapy (either amiodarone or ≥ 2 AADs) AND failed ablation (CA)
OR ablation (CA) contraindicated
Ability to understand study protocol and to write informed consent
Willing to comply with specified pre-, post- and follow-up testing, evaluations and requirements
Expected to remain available for at least 36 months after enrollment