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Trial record 3 of 1162 for:    adenosine

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

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ClinicalTrials.gov Identifier: NCT01932112
Recruitment Status : Completed
First Posted : August 30, 2013
Results First Posted : April 13, 2016
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Yong Seog Oh, Seoul St. Mary's Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Atrial Fibrillation
Persistent Common Pulmonary Vein
Intervention Drug: Adenosine arm
Enrollment 378
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Adenosine Arm
Hide Arm/Group Description

After pulmonary vein isolation, 20mg Iv adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.

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

Period Title: Overall Study
Started 378
Completed 378
Not Completed 0
Arm/Group Title Adenosine Arm
Hide Arm/Group Description

After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.

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

Overall Number of Baseline Participants 378
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 378 participants
60  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 378 participants
Female
123
  32.5%
Male
255
  67.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 378 participants
378
1.Primary Outcome
Title Reconnection of Pulmonary Vein Electrogram After Adenosine Infusion
Time Frame 5 minutes after IV adenosine
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adenosine Arm
Hide Arm/Group Description:

After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.

Adenosine arm: After pulmonary vein isolation, 12mg Iv adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.

Overall Number of Participants Analyzed 378
Measure Type: Number
Unit of Measure: participants
92
2.Secondary Outcome
Title Atrial Fibrillation Recurrence
Hide Description 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)
Time Frame between 0 and 12 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adenosine Arm
Hide Arm/Group Description

After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.

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

All-Cause Mortality
Adenosine Arm
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Adenosine Arm
Affected / at Risk (%) # Events
Total   2/378 (0.53%)    
Respiratory, thoracic and mediastinal disorders   
cough *  2/378 (0.53%)  2
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adenosine Arm
Affected / at Risk (%) # Events
Total   0/378 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Y. Oh, director of clinical trial
Organization: Seoul St Mary's hospital
Phone: 82-2-2258-1141
Responsible Party: Yong Seog Oh, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT01932112     History of Changes
Other Study ID Numbers: APPLE
First Submitted: August 14, 2013
First Posted: August 30, 2013
Results First Submitted: May 23, 2015
Results First Posted: April 13, 2016
Last Update Posted: April 26, 2017