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

Atrial Fibrillation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02175043
• Other study ID #: 4-2014-0282
• Status: Completed
• Phase: N/A
• First received: June 23, 2014
• Last updated: April 24, 2017
• Start date: June 3, 2014
• Est. completion date: February 28, 2017

Study information

• Verified date: April 2017
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 28, 2017
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Severance Cardiovascular Hospital, Yonsei University Health System	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of Clinical recurrence of atrial fibrillation (AF) after catheter ablation	lifelong, checked per every outpatient clinic visit	1 year