Adenosine Effect on Persistent Pulmonary Vein Isolation Line Evaluation (APPLE Trial) (APPLE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01932112|
Recruitment Status : Completed
First Posted : August 30, 2013
Results First Posted : April 13, 2016
Last Update Posted : April 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Persistent Common Pulmonary Vein||Drug: Adenosine arm||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||378 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adenosine Effect on Persistent Pulmonary Vein Isolation Line Evaluation (APPLE Trial)|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||May 2015|
single arm study
Drug: Adenosine arm
After pulmonary vein isolation,20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.
Other Name: APPLE
- Reconnection of Pulmonary Vein Electrogram After Adenosine Infusion [ Time Frame: 5 minutes after IV adenosine ]After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.
- Atrial Fibrillation Recurrence [ Time Frame: 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01932112
|Korea, Republic of|
|Seoul st Mary's Hospital|
|Seoul, Seocho-Ku, Korea, Republic of, 137-040|
|Principal Investigator:||Yong seog Oh, MD||Seoul St. Mary's Hospital|