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

Yonsei University

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Procedure: atrial electrogram and liner ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT02175043

4-2014-0282

Details and patient eligibility

About

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

3. In atrial fibrillation patients, the maintenance of normal sinus rhythm showed significant reduction of mortality.

4. drug therapy with anti-arrhythmic drug showed many complications and side effect, thus non-drug therapy such as catheter ablation is developed.

5. catheter ablation has been performed for 10years world-wide, and showed superior treatment outcome compared with drug therapy.

6. However, there are no consensus for proper ablation strategy in longstanding persistent atrial fibrillation.

7. additional ablation make extent of myocardial injury and paradoxically increase recurrence rate, thus still controversial.

8. Therefore, we will compare conventional linear ablation with additional complex fractionated atrial electrogram targeted catheter ablation.

9. Methods

10. Treatment of All patients with atrial fibrillation is performed according to the standard treatment guideline of atrial fibrillation.

11. there is no additional blood sampling, imaging study, or any other invasive procedure according to the inclusion of the study.

12. study contents

13. 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.

14. compare complex fractionated atrial electrogram before and after linear ablation.

Enrollment: 40 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

the operation to add in CFAE to conventional liner ablation

Experimental group

Description:

The group of positive control is the operation to add in CFAE to conventional liner ablation in persistent atrial fibrillation patients

Treatment:

Procedure: atrial electrogram and liner ablation

only doing conventional liner ablation

Active Comparator group

Description:

The group of negative is the operation to only doing conventional liner ablation with persistent atrial fibrillation

Treatment:

Procedure: atrial electrogram and liner ablation