The Evaluation for Prognostic Factors After Catheter Ablation of Atrial Fibrillation: Cohort Study

March 14, 2019 updated by: Yonsei University

1. Purpose of the study

1) To explore clinical recurrence associated clinical factors including age, sex, clinical, electrophysiological, anatomical, imaging, and serologic characteristics.

2) To develop simulation model to predict clinical recurrence and the efficacy of catheter ablation 2. Scientific evidence of the study

  1. In atrial fibrillation patients, the maintenance of normal sinus rhythm showed significant reduction of mortality.
  2. drug therapy with anti-arrhythmic drug showed many complications and side effect, thus non-drug therapy such as catheter ablation is developed.
  3. catheter ablation has been performed for 10years world-wide, and showed superior treatment outcome compared with drug therapy.
  4. clinical outcome after catheter ablation is affected not only by age, sex and underlying disease, but also by electrophysiologic, imaging, serologic and electroanatomical remodeling of the heart. However, there are few studies concerning these multifactorial variables.

3. Study population

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

3100

Contacts and Locations

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

Study Contact

  • Name: Hui-Nam Pak, MD
  • Phone Number: 82-2-2228-8459
  • Email: hnpak@yuhs.ac

Study Locations

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consecutive patients with atrial fibrillation who undergoing catheter ablation in Yonsei Cardiovascular hospital, Yonsei university health system, Seoul, Korea.

Description

Inclusion Criteria:

  • patients who undergoing catheter ablation of atrial fibrillation due to symptomatic, drug refractory atrial fibrillation

Exclusion Criteria:

  • patients who do not agree with study inclusion
  • permanent AF refractory to electrical cardioversion
  • AF with valvular disease ≥ grade 2
  • patients with left atrial diameter greater than 60mm
  • patients with age less than 19

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
Yonsei AF Cohort
Patients with atrial fibrillation who undergoing catheter ablation of atrial fibrillation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical recurrence of atrial fibrillation (AF) after catheter ablation
Time Frame: Participants will be followed for 5 year after catheter ablation
We defined recurrence of AF as any episode of AF or atrial tachycardia lasting longer than 30 sec. Patients were asked to attend scheduled outpatient follow-up appointments 2, 6, 12, 18, 24, 36, 48 and 60 months after catheter ablation.
Participants will be followed for 5 year after catheter ablation

Collaborators and Investigators

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

Sponsor

Yonsei University

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

May 1, 2014

Primary Completion (Anticipated)

February 1, 2029

Study Completion (Anticipated)

February 1, 2029

Study Registration Dates

First Submitted

April 16, 2014

First Submitted That Met QC Criteria

May 12, 2014

First Posted (Estimate)

May 14, 2014

Study Record Updates

Last Update Posted (Actual)

March 18, 2019

Last Update Submitted That Met QC Criteria

March 14, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2014-0104

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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