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

Atrial Fibrillation Clinical Trial

— APPLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01932112
• Other study ID #: APPLE
• Status: Completed
• Phase: Phase 3
• First received: August 14, 2013
• Last updated: April 24, 2017
• Start date: November 2012
• Est. completion date: May 2015

Study information

• Verified date: April 2017
• Source: Seoul St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 378
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed atrial fibrillation

• recurrence of symptomatic atrial fibrillation in spite of Antiarrhythmic drug use

• written informed consent

Exclusion Criteria:

• intracardiac thrombus

• pregnancy

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Common Pulmonary Vein

Intervention

Drug:
• Adenosine arm
After pulmonary vein isolation,20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.

Locations

Country	Name	City	State
Korea, Republic of	Seoul st Mary's Hospital	Seoul	Seocho-Ku

Sponsors (1)

Lead Sponsor	Collaborator
Yong Seog Oh

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reconnection of Pulmonary Vein Electrogram After Adenosine Infusion	After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.	5 minutes after IV adenosine
Secondary	Atrial Fibrillation Recurrence	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)	between 0 and 12 months