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Clinical Trials/NCT03821051
NCT03821051
Recruiting
Not Applicable

China Structural Ventricular Arrhythmias Registry, a Multicenter,Observational and Prospective Study.

China National Center for Cardiovascular Diseases1 site in 1 country2,000 target enrollmentOctober 24, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ventricular Arrythmia
Sponsor
China National Center for Cardiovascular Diseases
Enrollment
2000
Locations
1
Primary Endpoint
sustained tachycardia/ ventricular fibrillation or sudden cardiac death
Status
Recruiting
Last Updated
7 years ago

Overview

Brief Summary

This is an observational, prospective, multi-center registry ,aiming at building a risk stratification for malignant structural ventricular arrhythmias. 2000 participants will be recruited from 10 centers in China,with clinical data to be abstracted from medical records ,and blood samples to be collected for finding promising risk indicators.The follow-up should be made every 6 mouths.

Detailed Description

In China, the prevalence and risk factors of malignant ventricular arrhythmias remain unclear. In addition ,the mainstream treatment relies on implantable devices and medication.China Malignant Ventricular Arrhythmias Study is a nation-wide complex consisting of several interrelated studies, with the aim of building a risk stratification as well as a efficient and economic strategy for early prevention and treatment. Structural Ventricular Arrhythmias Registry, as a part of China Malignant Ventricular Arrhythmias Study, is an observational, prospective, multi-center registry, aiming at building a risk stratification for malignant structural ventricular arrhythmias. 2000 patients with definitive diagnosis will be recruited consecutively from 10 major arrhythmia centers distributed in 6 areas in China. At study entry, participants will be interviewed and asked to sign the informed consent. Demographic characteristics, medical history, clinical features, laboratory tests, imaging pictures, medications, procedures, and in-hospital outcomes of patients will be abstracted from medical records by well trained staffs .At the same time, blood samples will be collected to detect biological markers, like genes, inflammatory factors ,etc. Once enrolled, the participants will receive follow up every 6 mouths about condition of arrhythmia, medication, clinical events, etc.

Registry
clinicaltrials.gov
Start Date
October 24, 2017
End Date
October 24, 2027
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
China National Center for Cardiovascular Diseases
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • diagnosed as ventricular arrhythmia resulted by structural heart diseases, including ischemic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, dilated cardiomyopathy, hypertrophic cardiomyopathy, etc.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

sustained tachycardia/ ventricular fibrillation or sudden cardiac death

Time Frame: 5 years

event of sustained ventricular tachycardia/ ventricular fibrillation or sudden cardiac death

Secondary Outcomes

  • all-cause death(5 years)
  • episodes of arrhythmia(5 years)

Study Sites (1)

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