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Completed

NCT Number: NCT02175043

Clinical Benefits of Additional Complex Fractionated Atrial Electrogram Targeted Catheter Ablation for Longstanding Persistent Atrial Fibrillation

1. Purpose of the study

1) To compare clinical outcome, procedure time, complication rate of persistent atrial fibrillation patients between conventional additional linear ablation and additional complex fractionated atrial electrogram targeted 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. However, there are no consensus for proper ablation strategy in longstanding persistent atrial fibrillation. 5. additional ablation make extent of myocardial injury and paradoxically increase recurrence rate, thus still controversial. 6. Therefore, we will compare conventional linear ablation with additional complex fractionated atrial electrogram targeted catheter ablation.

3. Methods

1. Treatment of All patients with atrial fibrillation is performed according to the standard treatment guideline of atrial fibrillation. 2. there is no additional blood sampling, imaging study, or any other invasive procedure according to the inclusion of the study.

4. study contents

1. to evaluate superior ablation strategy in longstanding persistent atrial fibrillation

* compare conventional linear ablation with additional complex fractionated atrial electrogram targeted catheter ablation. both strategies are conventional ablation strategies being performed world-wide. 2. compare complex fractionated atrial electrogram before and after linear ablation.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severance Cardiovascular Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

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

atrial electrogram and liner ablation

Procedure
  • The group of positive control is the operation to add in CFAE to conventional liner ablation in persistent atrial fibrillation patients
  • The group of negative is the operation to only doing conventional liner ablation with persistent atrial fibrillation

Primary outcomes

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

    Time frame: 1 year

    lifelong, checked per every outpatient clinic visit

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 26, 2014
Registry last updated
Apr 25, 2017

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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