Evaluation of Proper Radiofrequency Catheter Ablation Strategy for the Patients Who Were Changed to Paroxysmal Atrial Fibrillation From Persistent Atrial Fibrillation

Yonsei University

Status: Enrolling

Conditions: Atrial Fibrillation

Treatments: Procedure: pulmonary vein isolation; Procedure: linear ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT02176616

4-2014-0279

Details and patient eligibility

About

1. Purpose of the study

1. To compare clinical outcome, procedure time, complication rate of patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation between ablation with conventional pulmonary vein isolation and ablation with conventional pulmonary vein isolation with conventional linear 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 patients who were changed to paroxysmal atrial fibrillation from 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 pulmonary vein isolation with additional conventional linear 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

1. to evaluate superior ablation strategy in patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation

• compare conventional pulmonary vein isolation with additional liner ablation, both strategies are conventional ablation strategies being performed world-wide.

Enrollment: 120 estimated 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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120 participants in 2 patient groups

linear ablation

Active Comparator group

Description:

The group of positive control is the operation to add in conventional liner ablation to conventional pulmonary vein isolation with in patients based on patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation

Treatment:

Procedure: linear ablation

pulmonary vein isolation

Experimental group

Description:

The group of negative is the operation to patients with only pulmonary vein isolation based on patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation

Treatment:

Procedure: pulmonary vein isolation