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Recruiting NCT07149701

Ventricular Tachycardia:A Registry Study

Observational Ventricular Tachycardia (VT) Structural Heart Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard Clinical Care.
Who it may be relevant to
Registry conditions: Ventricular Tachycardia (VT), Structural Heart Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Other 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.

Primary outcome measures

  • Composite of ventricular tachycardia recurrence or appropriate ICD therapy, unplanned cardiovascular hospitalization, or all-cause death [Time frame: 12 months]
Secondary outcome measures (9)
  • Ventricular tachycardia recurrence or appropriate ICD therapy [Time frame: 12 months]
  • Unplanned cardiovascular hospitalization [Time frame: 12 months]
  • Causes and number of unplanned cardiovascular hospitalizations [Time frame: 12 months]
  • Causes and number of cardiovascular emergency department visits [Time frame: 12 months]
  • All-cause mortality [Time frame: 12 months]
  • Cardiovascular mortality [Time frame: 12 months]
  • Change in health-related quality of life (SF-36) [Time frame: Baseline to 12 months]
  • Change in patient-reported outcome measures [Time frame: Baseline to 12 months]
  • Treatment-related major safety events [Time frame: 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Beijing Anzhen Hospital, Capital Medical University — Beijing

Identifiers

NCT: NCT07149701 · KS2025135

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗