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

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ClinicalTrials.gov Identifier: NCT02138695
Recruitment Status : Recruiting
First Posted : May 14, 2014
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
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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.

3. Study population


Condition or disease
Atrial Fibrillation

Study Design
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Study Type : Observational
Estimated Enrollment : 3100 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : May 2014
Estimated Primary Completion Date : February 2029
Estimated Study Completion Date : February 2029

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Yonsei AF Cohort
Patients with atrial fibrillation who undergoing catheter ablation of atrial fibrillation


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138695


Contacts
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Contact: Hui-Nam Pak, MD 82-2-2228-8459 hnpak@yuhs.ac

Locations
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Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Hui-Nam Pak    82-2-2228-8459    hnpak@yuhs.ac   
Sponsors and Collaborators
Yonsei University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02138695    
Other Study ID Numbers: 4-2014-0104
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Keywords provided by Yonsei University:
atrial fibrillation
catheter ablation
recurrence
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes