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

NCT ID: NCT02175043

Last Updated: 2017-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-03
• Study Completion Date: 2017-02-28

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

the operation to add in CFAE to conventional liner ablation

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

Group Type: EXPERIMENTAL

atrial electrogram and liner ablation

Intervention Type: PROCEDURE

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

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

only doing conventional liner ablation

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

Group Type: ACTIVE_COMPARATOR

atrial electrogram and liner ablation

Intervention Type: PROCEDURE

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

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

Interventions

atrial electrogram and liner ablation

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

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Severance Cardiovascular Hospital, Yonsei University Health System

Seoul, , South Korea

Countries

South Korea

Other Identifiers

4-2014-0282

Identifier Type: -

Identifier Source: org_study_id