Adenosine Effect on Persistent Pulmonary Vein Isolation Line Evaluation (APPLE Trial)

Phase 3

Completed

• Conditions: Persistent Common Pulmonary Vein; Atrial Fibrillation
• Interventions: Drug: Adenosine arm

• Registration Number: NCT01932112
• Lead Sponsor: Yong Seog Oh

Brief Summary

The investigators studied the effects of adenosine on the reconnection rate after successful pulmonary veins isolation by radiofrequency catheter ablation in patients with drug-resistant atrial fibrillation

Detailed Description

Pulmonary vein isolation has emerged as an effective therapy for paroxysmal atrial fibrillation. However, atrial fibrillation recurs in up to 50% of patients, generally because of recovery of pulmonary vein conduction.

Adenosine given during the initial procedure may reveal dormant pulmonary vein conduction, thereby identifying the need for additional ablation, leading to improved outcomes.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-08-14
• Study First Submitted QC: 2013-08-26
• Study First Posted: 2013-08-30
• Primary Completion: 2015-04
• Study Completion: 2015-05
• Results First Submitted: 2015-05-23
• Results First Submitted QC: 2016-03-14
• Results First Posted: 2016-04-13
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 378

Inclusion Criteria

• Diagnosed atrial fibrillation
• recurrence of symptomatic atrial fibrillation in spite of Antiarrhythmic drug use
• written informed consent

Exclusion Criteria

• intracardiac thrombus
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
adenosine arm	Adenosine arm	single arm study

Primary Outcome Measures

Name	Time	Method
Reconnection of Pulmonary Vein Electrogram After Adenosine Infusion	5 minutes after IV adenosine	After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.

Secondary Outcome Measures

Name	Time	Method
Atrial Fibrillation Recurrence	between 0 and 12 months	At 1 month, 3 month, 6 month and 12 months post ablation routine clinic visits, will perform electrocardiographically documented by electrogram (At 1,3,6,12 months post ablation) and Holter monitoring (At 12 months post ablation)

Trial Locations

Locations (1)

Seoul st Mary's Hospital; 🇰🇷 Seoul, Seocho-Ku, Korea, Republic of