Ventricular Tachycardia：A Registry Study

Обзор

Structural heart disease-related ventricular tachycardia (SHD-VT) is associated with substantial morbidity and mortality. Although catheter ablation, ICD therapy, antiarrhythmic drugs, and other treatment strategies are widely used, real-world evidence regarding patient characteristics, management patterns, long-term outcomes, and prognostic factors in China remains limited. This nationwide, multicenter, prospective observational registry aims to establish a comprehensive longitudinal database of patients with SHD-VT. Approximately 1,000 consecutive adult patients with documented sustained ventricular tachycardia, or clinically significant nonsustained ventricular tachycardia requiring treatment, in the presence of structural heart disease will be enrolled and followed prospectively. The study will collect detailed demographic characteristics, medical history, imaging findings, laboratory data, electrophysiological characteristics, treatment strategies, and follow-up outcomes without influencing routine clinical management. The primary effectiveness outcome is a composite of ventricular tachycardia recurrence or appropriate ICD therapy (when applicable), unplanned cardiovascular hospitalization, or all-cause death within 12 months. Long-term follow-up will continue to evaluate clinical outcomes, treatment safety, and prognostic factors. The registry is expected to provide high-quality real-world evidence to improve risk stratification, optimize clinical decision-making, and support future clinical research in patients with SHD-VT.

Вмешательства

• Другое Standard Clinical Care
  Participants will receive standard clinical care as determined by their treating physicians. Treatment strategies, including antiarrhythmic drug therapy, catheter ablation, implantable cardioverter-defibrillator (ICD) implantation, cardiac resynchronization therapy with defibrillator (CRT-D), surgical interventions, and other clinically indicated therapies, will be recorded. No treatment is assigned or influenced by the study protocol.

Первичные конечные точки

• Composite of ventricular tachycardia recurrence or appropriate ICD therapy, unplanned cardiovascular hospitalization, or all-cause death [Срок оценки: 12 months]

Вторичные конечные точки (9)

• Ventricular tachycardia recurrence or appropriate ICD therapy [Срок оценки: 12 months]
• Unplanned cardiovascular hospitalization [Срок оценки: 12 months]
• Causes and number of unplanned cardiovascular hospitalizations [Срок оценки: 12 months]
• Causes and number of cardiovascular emergency department visits [Срок оценки: 12 months]
• All-cause mortality [Срок оценки: 12 months]
• Cardiovascular mortality [Срок оценки: 12 months]
• Change in health-related quality of life (SF-36) [Срок оценки: Baseline to 12 months]
• Change in patient-reported outcome measures [Срок оценки: Baseline to 12 months]
• Treatment-related major safety events [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Adults aged ≥18 years.
• Documented sustained ventricular tachycardia (VT), or nonsustained VT requiring therapeutic intervention in the investigator's judgment, confirmed by a 12-lead electrocardiogram, ambulatory electrocardiographic monitoring, continuous cardiac monitoring, implantable cardiac device recordings, or electrophysiological study.
• Structural heart disease diagnosed according to current clinical guidelines.
• Willing and able to provide written informed consent.
• Willing to comply with the study follow-up schedule.

Критерии исключения

• Ventricular tachycardia secondary to reversible causes (e.g., acute myocardial ischemia or electrolyte disturbances).
• Idiopathic ventricular tachycardia without evidence of structural heart disease.
• Cardiac surgery within 60 days before enrollment.
• Severe infectious diseases (e.g., septic shock or sepsis).
• Severe coagulation disorders, including platelet count <50 × 10⁹/L or disseminated intravascular coagulation.
• Participation in another interventional clinical study that may interfere with this registry.
• Any other condition that, in the investigator's judgment, makes the participant unsuitable for study participation.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Beijing Anzhen Hospital, Capital Medical University — Пекин

Идентификаторы

NCT: NCT07149701 · KS2025135

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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