Ventricular Tachycardia：A Registry Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Composite of ventricular tachycardia recurrence or appropriate ICD therapy, unplanned cardiovascular hospitalization, or all-cause death
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
SHD-VT Cohort
This cohort includes consecutive adult patients with structural heart disease and documented sustained ventricular tachycardia, or clinically significant nonsustained ventricular tachycardia requiring treatment, enrolled in a prospective multicenter observational registry. All treatment decisions are made according to routine clinical practice without study intervention.
干预措施: Standard Clinical Care (Other)
结局指标
主要结局
Composite of ventricular tachycardia recurrence or appropriate ICD therapy, unplanned cardiovascular hospitalization, or all-cause death
时间窗: 12 months
Time to the first occurrence of ventricular tachycardia recurrence or appropriate implantable cardioverter-defibrillator (ICD) therapy (when applicable), unplanned cardiovascular hospitalization, or all-cause death.
次要结局
- Ventricular tachycardia recurrence or appropriate ICD therapy(12 months)
- Unplanned cardiovascular hospitalization(12 months)
- Causes and number of unplanned cardiovascular hospitalizations(12 months)
- Causes and number of cardiovascular emergency department visits(12 months)
- All-cause mortality(12 months)
- Cardiovascular mortality(12 months)
- Change in health-related quality of life (SF-36)(Baseline to 12 months)
- Change in patient-reported outcome measures(Baseline to 12 months)
- Treatment-related major safety events(12 months)