Меню
Набор скоро начнётся NCT06455020

Catheter Ablation of Haemodynamically Not-tolerated Electrical Storm in Structural Heart Disease

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: Catheter ablation, Stepped-care strategies.
Кому может быть актуально
Состояния в реестре: Ventricular Tachycardia. Базовые параметры: 18 лет — 80 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

This is a multi-center, parallel-group, randomized, open-label trial evaluating the clinical outcome and efficacy of emergency catheter ablation versus conventional stepped-care strategies in patients with haemodynamically not-tolerated ventricular tachycardia (VT).

Подробное описание

The prognosis of haemodynamically not-tolerated VT in structural heart disease is very poor, with a high 30-day mortality rate \>30%, resulting in extremely heavy medical burden. Current guidelines lack specific recommendations for managing this condition. The prevailing treatment strategy involves a sequential approach-beginning with anti-arrhythmic drugs, sedation, and anesthesia, followed by haemodynamic mechanical support devices. Catheter ablation is only used as the final rescue treatment. Typically, patients undergo repeated electrical cardioversion and receive multiple vasopressors and antiarrhythmic drugs, facing increased risks of complications from enhanced haemodynamic support. Studies have shown that these patients often eventually progress to irreversible pump failure, miss the window for effective catheter ablation, and ultimately die. Early cardioversion and maintenance of sinus rhythm, may significantly reduce mortality rates in patients with haemodynamically not-tolerated VT. Therefore, emergency catheter ablation is expected to reduce the mortality of haemodynamically not-tolerated ventricular tachycardia.

In this study, we aim to evaluate the effect of emergency catheter ablation in haemodynamically not-tolerated ventricular tachycardia. Current study will include 96 patients, and all patients will be randomized to either the emergency catheter ablation arm or stepped-care strategies arm in a 1:1 fashion. The follow-up duration is 1 year. The primary outcome is a composite outcome of VT recurrence, cardiovascular re-hospitalization, and all-cause mortality.

Вмешательства

  • Процедура Catheter ablation
    Emergency catheter ablation is defined as ablation performed within 48 hours of hospital admission
  • Процедура Stepped-care strategies
    Patients randomized to the stepped-care strategy arm will receive treatment through a systematic, stepwise protocol beginning with anti-arrhythmic drugs, followed by sedation and anesthesia, and progressing to haemodynamic mechanical support devices if earlier treatments prove ineffective. Catheter ablation will be reserved as the final rescue intervention.

Первичные конечные точки

  • Composite outcomes of ventricular tachycardia recurrence, cardiovascular hospitalization, or death during the 30-day follow-up [Срок оценки: 30 days]
Вторичные конечные точки (5)
  • Recurrence of ventricular tachycardia during the 30-day follow-up [Срок оценки: 30 days]
  • Cardiovascular re-hospitalization during the 30-day follow-up [Срок оценки: 30 days]
  • All-cause mortality during the 30-day follow-up [Срок оценки: 30 days]
  • Composite outcomes of ventricular tachycardia recurrence, cardiovascular hospitalization, or death during the 1-year follow-up [Срок оценки: 1 year]
  • All-cause mortality during the 1-year follow-up [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • Patients aged 18 to 80 years;
  • Having structural heart disease, including ischemic cardiomyopathy and nonischemic cardiomyopathy;
  • Haemodynamically not-tolerated, defined as persistent hypotension (systolic blood pressure <90 mmHg and mean arterial pressure 30 mmHg lower than baseline or <70 mmHg, with associated signs of end-organ hypoperfusion);
  • Electrical storm, defined as >3 VT episodes within 24 hours.

Критерии исключения

  • Reversible causes of ventricular tachycardia or cardiomyopathy;
  • Ventricular thrombosis diagnosed by echocardiography and/or cardiac magnetic resonance;
  • Acute ST-segment-elevation myocardial infarction within 60 days;
  • Cardiac surgery within 60 days;
  • Unstable angina;
  • Pregnancy.

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

Китай · 4 центра
  • Beijing Anzhen Hospital, Capital Medical University — Пекин
  • Second Xiangya Hospital, Central South University — Чанша
  • The Affiliated YanAn Hospital of KunMing Medical University — Куньмин
  • The First Affiliated Hospital of Nanjing Medical University — Нанкин

Идентификаторы

NCT: NCT06455020 · 2024-vtstorm

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗