URGENT: Acute Cerebrovascular Events Secondary to Patients Undergoing Catheter Ablation to Arrhythmias

Sponsor

First Affiliated Hospital Xi'an Jiaotong University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05694273

Collaborator

(none)

100

Enrollment

Location

3.3

Anticipated Duration (Months)

30.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Arrhythmia Ischemic Stroke Hemorrhagic Stroke	Procedure: Radiofrequency catheter ablation

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Acute Cerebrovascular Events Secondary to Patients Undergoing Catheter Ablation to Arrhythmias (URGENT): an Investigator-initiated, National Multicenter Real-world Study

Anticipated Study Start Date :

Jan 20, 2023

Anticipated Primary Completion Date :

Mar 30, 2023

Anticipated Study Completion Date :

Apr 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Ischemic stroke group Ischemic stroke secondary to patients receiving cardiac electronic implants Ischemic stroke met the diagnostic criteria of the 2018 edition of the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke, and was confirmed by cranial CT/MRI scan.	Procedure: Radiofrequency catheter ablation Catheter ablation has traditionally been used primarily in isolated Supraventricular tachycardias (SVT), atrioventricular nodal reentry tachycardias (AVNRT) are the most common paroxysmal SVTS. In recent years, the pathophysiological understanding of SVTS and catheter ablation have steadily advanced. Radiofrequency catheter ablation currently dominates AVNRT due to the high recurrence rate after cryoablation.
Transient ischemic attack group Transient ischemic attack secondary to patients receiving cardiac electronic implants Ischemic stroke met the diagnostic criteria of the 2018 edition of the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke, and was confirmed negative of new onset of infarction by cranial CT/MRI scan.	Procedure: Radiofrequency catheter ablation Catheter ablation has traditionally been used primarily in isolated Supraventricular tachycardias (SVT), atrioventricular nodal reentry tachycardias (AVNRT) are the most common paroxysmal SVTS. In recent years, the pathophysiological understanding of SVTS and catheter ablation have steadily advanced. Radiofrequency catheter ablation currently dominates AVNRT due to the high recurrence rate after cryoablation.
Cerebral hemorrhage group Cerebral hemorrhage secondary to patients receiving cardiac electronic implants Cerebral hemorrhage met the diagnostic criteria of the 2021 Chinese Guidelines for the Diagnosis and Treatment of cerebral hemorrhage and was confirmed by head CT/MRI.	Procedure: Radiofrequency catheter ablation Catheter ablation has traditionally been used primarily in isolated Supraventricular tachycardias (SVT), atrioventricular nodal reentry tachycardias (AVNRT) are the most common paroxysmal SVTS. In recent years, the pathophysiological understanding of SVTS and catheter ablation have steadily advanced. Radiofrequency catheter ablation currently dominates AVNRT due to the high recurrence rate after cryoablation.

Arm

Intervention/Treatment

Ischemic stroke group

Ischemic stroke secondary to patients receiving cardiac electronic implants Ischemic stroke met the diagnostic criteria of the 2018 edition of the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke, and was confirmed by cranial CT/MRI scan.

Procedure: Radiofrequency catheter ablation

Catheter ablation has traditionally been used primarily in isolated Supraventricular tachycardias (SVT), atrioventricular nodal reentry tachycardias (AVNRT) are the most common paroxysmal SVTS. In recent years, the pathophysiological understanding of SVTS and catheter ablation have steadily advanced. Radiofrequency catheter ablation currently dominates AVNRT due to the high recurrence rate after cryoablation.

Transient ischemic attack group

Transient ischemic attack secondary to patients receiving cardiac electronic implants Ischemic stroke met the diagnostic criteria of the 2018 edition of the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke, and was confirmed negative of new onset of infarction by cranial CT/MRI scan.

Procedure: Radiofrequency catheter ablation

Cerebral hemorrhage group

Cerebral hemorrhage secondary to patients receiving cardiac electronic implants Cerebral hemorrhage met the diagnostic criteria of the 2021 Chinese Guidelines for the Diagnosis and Treatment of cerebral hemorrhage and was confirmed by head CT/MRI.

Procedure: Radiofrequency catheter ablation

Outcome Measures

Primary Outcome Measures

The prevalence of acute cerebrovascular disease [up to 4 weeks in hospital]
Number and rate of patients with acute cerebrovascular disease secondary to patients receiving radiofrequency catheter ablation

Secondary Outcome Measures

In-hospital mortality [up to 4 weeks in hospital]
In-hospital mortality of acute cerebrovascular disease in patients receiving radiofrequency catheter ablation
all-cause mortality [3 months]
all-cause mortality within 3 months of telephone follow-up

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1.Clinical diagnosis of acute cerebrovascular disease secondary to radiofrequency catheter ablation.
2.Hospitalized from January 2018 to September 2022.

Exclusion Criteria:

1. Patients were diagnosed of acute cerebrovascular disease prior to radiofrequency catheter ablation.
1. Patients refuse to take follow-up interviews.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Affiliated Hospital of Xian Jiantong University	Xi'an	Shaanxi	China	710061

Sponsors and Collaborators

First Affiliated Hospital Xi'an Jiaotong University

Investigators

Principal Investigator: guoliang li, First Affiliated Hospital Xi'an Jiaotong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

First Affiliated Hospital Xi'an Jiaotong University

ClinicalTrials.gov Identifier:

NCT05694273

Other Study ID Numbers:

XJTU1AF2023LSK-005

First Posted:

Jan 23, 2023

Last Update Posted:

Jan 23, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by First Affiliated Hospital Xi'an Jiaotong University

Radiofrequency catheter ablation；Arrhythmia；Stroke

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 23, 2023