Ventricular Tachycardia:A Registry Study
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Contact
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
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Contact:
- Deyong Long, MD
- Phone Number: +86 (010) 84005361
- Email: dragon2008@vip.sina.com
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Composite of ventricular tachycardia recurrence or appropriate ICD therapy, unplanned cardiovascular hospitalization, or all-cause death
Time Frame: 12 months
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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.
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12 months
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Ventricular tachycardia recurrence or appropriate ICD therapy
Time Frame: 12 months
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Time to the first documented ventricular tachycardia recurrence or first appropriate implantable cardioverter-defibrillator (ICD) therapy, when applicable.
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12 months
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Unplanned cardiovascular hospitalization
Time Frame: 12 months
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Time to the first unplanned hospitalization for cardiovascular causes.
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12 months
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Causes and number of unplanned cardiovascular hospitalizations
Time Frame: 12 months
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Causes of unplanned cardiovascular hospitalizations and the total number of hospitalization episodes during follow-up.
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12 months
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Causes and number of cardiovascular emergency department visits
Time Frame: 12 months
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Causes and total number of emergency department visits for cardiovascular conditions during follow-up.
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12 months
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All-cause mortality
Time Frame: 12 months
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Death from any cause during follow-up.
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12 months
|
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Cardiovascular mortality
Time Frame: 12 months
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Death attributable to cardiovascular causes during follow-up.
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12 months
|
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Change in health-related quality of life (SF-36)
Time Frame: Baseline to 12 months
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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
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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
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Occurrence of treatment-related major safety events, including catheter ablation-related complications, ICD-related complications, serious adverse drug reactions, and other serious adverse events.
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12 months
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Deyong Long, Beijing Anzhen Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- KS2025135
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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