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

Atrial Fibrillation Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02138695
• Other study ID #: 4-2014-0104
• Status: Recruiting
• Start date: May 2014
• Est. completion date: February 2029

Study information

• Verified date: March 2019
• Source: Yonsei University
• Contact: Hui-Nam Pak, MD
• Phone: 82-2-2228-8459
• Email: hnpak[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3100
• Est. completion date: February 2029
• Est. primary completion date: February 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical recurrence of atrial fibrillation (AF) 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