- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07149701
- Original Trial
Ventricular Tachycardia:A Registry Study
July 27, 2026 updated by: Beijing Anzhen Hospital
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Deyong Long, MD
- Phone Number: +86 (010) 84005361
- Email: dragon2008@vip.sina.com
Study Contact Backup
- Name: Deyong Long
- Phone Number: +86 (010) 84005361
- Email: dragon2008@vip.sina.com
Study Locations
-
-
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Beijing, China
- Recruiting
- Beijing Anzhen Hospital, Capital Medical University
-
Contact:
- Deyong Long, MD
- Phone Number: +86 (010) 84005361
- Email: dragon2008@vip.sina.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Composite of ventricular tachycardia recurrence or appropriate ICD therapy, unplanned cardiovascular hospitalization, or all-cause death
Time Frame: 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.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ventricular tachycardia recurrence or appropriate ICD therapy
Time Frame: 12 months
|
Time to the first documented ventricular tachycardia recurrence or first appropriate implantable cardioverter-defibrillator (ICD) therapy, when applicable.
|
12 months
|
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Unplanned cardiovascular hospitalization
Time Frame: 12 months
|
Time to the first unplanned hospitalization for cardiovascular causes.
|
12 months
|
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Causes and number of unplanned cardiovascular hospitalizations
Time Frame: 12 months
|
Causes of unplanned cardiovascular hospitalizations and the total number of hospitalization episodes during follow-up.
|
12 months
|
|
Causes and number of cardiovascular emergency department visits
Time Frame: 12 months
|
Causes and total number of emergency department visits for cardiovascular conditions during follow-up.
|
12 months
|
|
All-cause mortality
Time Frame: 12 months
|
Death from any cause during follow-up.
|
12 months
|
|
Cardiovascular mortality
Time Frame: 12 months
|
Death attributable to cardiovascular causes during follow-up.
|
12 months
|
|
Change in health-related quality of life (SF-36)
Time Frame: Baseline to 12 months
|
Change in the Short Form-36 (SF-36) score from baseline.
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Baseline to 12 months
|
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Change in patient-reported outcome measures
Time Frame: 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.
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Baseline to 12 months
|
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Treatment-related major safety events
Time Frame: 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.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Deyong Long, Beijing Anzhen Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 14, 2025
Primary Completion (Estimated)
September 1, 2029
Study Completion (Estimated)
December 1, 2029
Study Registration Dates
First Submitted
August 24, 2025
First Submitted That Met QC Criteria
August 24, 2025
First Posted (Actual)
September 2, 2025
Study Record Updates
Last Update Posted (Actual)
July 29, 2026
Last Update Submitted That Met QC Criteria
July 27, 2026
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KS2025135
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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