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

Sponsor
Yonsei University (Other)
Overall Status
Recruiting
CT.gov ID
NCT02138695
Collaborator
(none)
3,100
Enrollment
1
Location
177.1
Duration (Months)
17.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

  5. Study population

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    3100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Study Start Date :
    May 1, 2014
    Anticipated Primary Completion Date :
    Feb 1, 2029
    Anticipated Study Completion Date :
    Feb 1, 2029

    Arms and Interventions

    Arm Intervention/Treatment
    Yonsei AF Cohort

    Patients with atrial fibrillation who undergoing catheter ablation of atrial fibrillation

    Outcome Measures

    Primary Outcome Measures

    1. Clinical recurrence of atrial fibrillation (AF) after catheter ablation [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Severance Hospital Seoul Korea, Republic of 120-752

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT02138695
    Other Study ID Numbers:
    • 4-2014-0104
    First Posted:
    May 14, 2014
    Last Update Posted:
    Mar 18, 2019
    Last Verified:
    Mar 1, 2019
    Keywords provided by Yonsei University
    atrial fibrillation
    catheter ablation
    recurrence
    Additional relevant MeSH terms:
    Atrial Fibrillation

    Study Results

    No Results Posted as of Mar 18, 2019