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

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: atrial electrogram and liner ablation

• Registration Number: NCT02175043
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-03
• Study First Submitted: 2014-06-23
• Study First Submitted QC: 2014-06-24
• Study First Posted: 2014-06-26
• Primary Completion: 2017-02-28
• Study Completion: 2017-02-28
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. patients who undergoing catheter ablation of atrial fibrillation due to symptomatic, drug refractory atrial fibrillation

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Exclusion Criteria

1. patients who do not agree with study inclusion
2. permanent AF refractory to electrical cardioversion
3. AF with valvular disease ≥ grade 2
4. Patients with left atrial diameter greater than 60mm
5. patients with age less than 19

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
only doing conventional liner ablation	atrial electrogram and liner ablation	The group of negative is the operation to only doing conventional liner ablation with persistent atrial fibrillation
the operation to add in CFAE to conventional liner ablation	atrial electrogram and liner ablation	The group of positive control is the operation to add in CFAE to conventional liner ablation in persistent atrial fibrillation patients

Primary Outcome Measures

Name	Time	Method
number of Clinical recurrence of atrial fibrillation (AF) after catheter ablation	1 year	lifelong, checked per every outpatient clinic visit

Trial Locations

Locations (1)

Severance Cardiovascular Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of