NCT07149701

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
40mo left

Started Oct 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
Oct 2025Dec 2029

First Submitted

Initial submission to the registry

August 24, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 2, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

October 14, 2025

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

July 29, 2026

Status Verified

August 1, 2025

Enrollment Period

3.9 years

First QC Date

August 24, 2025

Last Update Submit

July 27, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Composite of ventricular tachycardia recurrence or appropriate ICD therapy, unplanned cardiovascular hospitalization, or all-cause death

    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.

    12 months

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (1)

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.

Other: Standard Clinical Care

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.

SHD-VT Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with documented sustained ventricular tachycardia (VT), or nonsustained VT requiring therapeutic intervention, in the presence of structural heart disease. Participants will be consecutively enrolled from multiple hospitals in China and managed according to routine clinical practice.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Biospecimens collected in this study may include, but are not limited to, whole blood, plasma, serum, peripheral blood mononuclear cells (PBMCs), and other ethically approved residual clinical specimens.

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Deyong Long

    Beijing Anzhen Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2025

First Posted

September 2, 2025

Study Start

October 14, 2025

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

July 29, 2026

Record last verified: 2025-08

Locations