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NCT Number: NCT02138695

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

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

Recruiting

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Disease Attributes Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hui-Nam Pak, MD

CONTACT

[email protected]

82-2-2228-8459

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2014
Primary completion
2029
Study completion
2029
First posted
May 14, 2014
Registry last updated
Mar 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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