Ventricular Tachycardia (VT), Structural Heart Disease
Conditions
Brief summary
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.
Interventions
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.
Sponsors
Beijing Anzhen Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of ventricular tachycardia recurrence or appropriate ICD therapy, unplanned cardiovascular hospitalization, or all-cause death | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ventricular tachycardia recurrence or appropriate ICD therapy | 12 months | Time to the first documented ventricular tachycardia recurrence or first appropriate implantable cardioverter-defibrillator (ICD) therapy, when applicable. |
| Unplanned cardiovascular hospitalization | 12 months | Time to the first unplanned hospitalization for cardiovascular causes. |
| Causes and number of unplanned cardiovascular hospitalizations | 12 months | Causes of unplanned cardiovascular hospitalizations and the total number of hospitalization episodes during follow-up. |
| Causes and number of cardiovascular emergency department visits | 12 months | Causes and total number of emergency department visits for cardiovascular conditions during follow-up. |
| All-cause mortality | 12 months | Death from any cause during follow-up. |
| Cardiovascular mortality | 12 months | Death attributable to cardiovascular causes during follow-up. |
| Change in health-related quality of life (SF-36) | Baseline to 12 months | Change in the Short Form-36 (SF-36) score from baseline. |
| Change in patient-reported outcome measures | Baseline to 12 months | Change from baseline in patient-reported outcomes, including the Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Pittsburgh Sleep Quality Index (PSQI), and other validated scales, as applicable. |
| Treatment-related major safety events | 12 months | Occurrence of treatment-related major safety events, including catheter ablation-related complications, ICD-related complications, serious adverse drug reactions, and other serious adverse events. |
Countries
China
Contacts
CONTACTDeyong Long, MD
CONTACTDeyong Long
PRINCIPAL_INVESTIGATORDeyong Long
Beijing Anzhen Hospital
Outcome results
None listed