Acute Cerebrovascular Events in Patients Undergoing Catheter Ablation

Arrhythmia Clinical Trial

— CENTRAL  

Official title:

Acute Cerebrovascular Events in Patients Undergoing Catheter Ablation (CENTRAL): an Investigator-initiated, Multicenter Real-world Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05694273
• Other study ID #: XJTU1AF2023LSK-531
• Status: Not yet recruiting
• Start date: January 15, 2025
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2024
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Guoliang li
• Phone: +8613759982523
• Email: liguoliang_med[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to evaluate the incidence, clinical characteristics, and short-term prognosis of acute cerebrovascular events occurring in-hospital in patients with arrhythmias following catheter ablation. The goal is to provide evidence supporting the improvement of patient quality of life and reduction of in-hospital acute cerebrovascular complications in patients with post-ablation arrhythmias. This will also contribute to the evidence-based clinical management of such patients.

Description:

With the steady development of catheter ablation, it has gradually become the main treatment of various arrhythmias. Antithrombotic and anticoagulant therapy after catheter ablation determines the occurrence of perioperative bleeding and ischemic events. However, the incidence, characteristics and short-term prognosis of secondary acute cerebrovascular events in patients with arrhythmia after catheter ablation have not been studied. Methods: This study was intended to retrospectively collect and analyze the case data and auxiliary examination results of patients with arrhythmia who underwent catheter ablation. To evaluate the incidence, clinical features and short-term prognosis of secondary acute ischemic and hemorrhagic cerebrovascular events in patients with arrhythmia after catheter ablation. In order to improve the quality of life of patients, reduce the secondary acute cerebrovascular complications in the hospital in patients with arrhythmia after catheter ablation, to provide evidence for promoting the clinical management of such patients, and to provide help for the maximum degree of prevention and control risk.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 1.Patients who undergo catheter ablation for arrhythmias.

Exclusion Criteria:

• 1. Patients were diagnosed of acute cerebrovascular disease prior to radiofrequency catheter ablation;
• 2. Patients < 18 years or > 80 years;
• 3. Patients with uncomplete clinical data.

Related Conditions & MeSH terms

• Arrhythmia
• Arrhythmias, Cardiac
• Cerebrovascular Disorders

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xian Jiantong University	Xi'an	Shaanxi

Sponsors (11)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	521 Hospital of NORINCO Group, Ankang Central Hospital, Baoji Central Hospital, Chinese Academy of Medical Sciences, Fuwai Hospital, Fu Wai Hospital, Beijing, China, Fuwai Yunnan Cardiovascular Hospital, Luoyang Central Hospital, Shaanxi Provincial People's Hospital, Tianjin Medical University Second Hospital, Xiangyang Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of MACCE	Major adverse cardiovascular and cerebrovascular events, a composite of all-cause mortality, myocardial infarction and stroke. The data will be obtained at 3-month follow-up, according to medical records of all patients.	3 months after enrollment
Secondary	Incidence of all-cause mortality	The data will be obtained at 3-month follow-up, according to medical records of all patients.	3 months after enrollment
Secondary	Incidence of myocardial infarction	The data will be obtained at 3-month follow-up, according to medical records of all patients.	3 months after enrollment
Secondary	Incidence of stroke	The data will be obtained at 3-month follow-up, according to medical records of all patients.	3 months after enrollment