Risk Factors of Stroke or Systemic Embolism After Atrial Fibrillation Ablation

June 14, 2018 updated by: Hong Euy Lim, MD, Korea University Guro Hospital

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

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

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

3198

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of
        • Korea University Anam Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study population was extracted from a consortium of registry of AF ablation by three University Hospitals (Korea univ Guro, Korea univ Anam and Seoul National University) from 1998 to 2016.

Description

Inclusion Criteria:

  • Patients who underwent catheter ablation for AF

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Stroke group
Patients who experienced stroke or systemic embolic event following catheter ablation for AF.
Control group
Patients who did not experienced stroke or systemic embolic event following catheter ablation for AF.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of stroke or systemic embolism after AF ablation
Time Frame: 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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Guro Hospital

Collaborators

Hanmi Pharmaceutical Company Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2017

Primary Completion (Actual)

June 14, 2018

Study Completion (Actual)

June 14, 2018

Study Registration Dates

First Submitted

March 6, 2018

First Submitted That Met QC Criteria

March 20, 2018

First Posted (Actual)

March 27, 2018

Study Record Updates

Last Update Posted (Actual)

June 18, 2018

Last Update Submitted That Met QC Criteria

June 14, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUGH17098-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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