Risk Factors of Stroke or Systemic Embolism After Atrial Fibrillation Ablation

Atrial Fibrillation Clinical Trial

Official title:

The Characteristics of Patients Experiencing Stroke or Systemic Embolism During Follow up Period After Atrial Fibrillation Ablation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03479073
• Other study ID #: KUGH17098-001
• Status: Completed
• Start date: May 17, 2017
• Est. completion date: June 14, 2018

Study information

• Verified date: June 2018
• Source: Korea University Guro Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To investigate the rate and risk factors of stroke or systemic embolism (SE) following atrial fibrillation (AF) ablation.

Description:

Since catheter ablation for AF reduces the burden of AF effectively, several studies have demonstrated that catheter ablation not only improves the quality of life but also reduces the risk of stroke and all cause mortality. However, until now the guideline has recommended the continuation of oral anticoagulation (OAC) therapy in patients who are at risk of stroke or systemic embolism (SE) based on the CHA2DS2-VASc score, even though they have sinus rhythm following catheter ablation. The aims of this retrospective study is to assess the rate of stroke/SE during follow-up period after AF ablation and identify the independent risk factors for stroke/SE in patients who underwent catheter ablation for AF.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3198
• Est. completion date: June 14, 2018
• Est. primary completion date: June 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients who underwent catheter ablation for AF

Exclusion Criteria:

Related Conditions & MeSH terms

• Atrial Fibrillation
• Embolism

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Korea University Guro Hospital	Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of stroke or systemic embolism after AF ablation	Risk factors for stroke or systemic embolism after AF ablation	From the time of catheter ablation until the date of the last visit or the date of event.(Retrospective period of up to 20 years)