NCT02175043

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

Completed NA Last updated 25 April 2017

What this trial tests

NA trial testing atrial electrogram and liner ablation in Atrial Fibrillation in 40 participants. Completed in 28 February 2017.

Timeline

3 June 2014

Primary endpoint
28 February 2017

28 February 2017

Quick facts

Lead sponsor	Yonsei University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	40
Start date	3 June 2014
Primary completion	28 February 2017
Estimated completion	28 February 2017
Sites	1 location across South Korea

Drugs / interventions tested

• atrial electrogram and liner ablation

Conditions studied

• Atrial Fibrillation — all drugs for Atrial Fibrillation →

Sponsor

Yonsei University

Who can join

19 and older, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Does Additional Electrogram-Guided Ablation After Linear Ablation Reduce Recurrence After Catheter Ablation for Longstanding Persistent Atrial Fibrillation? A Prospective Randomized Study.
   Kim TH, Uhm JS, Kim JY, Joung B, et al · · 2017 · cited 31× · PMID 28174170 · DOI 10.1161/jaha.116.004811