Adenosine Effect on Persistent Pulmonary Vein Isolation Line Evaluation (APPLE Trial)
APPLE
1 other identifier
interventional
378
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 atrial-fibrillation
Started Nov 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 14, 2013
CompletedFirst Posted
Study publicly available on registry
August 30, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedResults Posted
Study results publicly available
April 13, 2016
CompletedApril 26, 2017
April 1, 2017
2.4 years
August 14, 2013
May 23, 2015
April 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Atrial Fibrillation Recurrence
between 0 and 12 months
Study Arms (1)
adenosine arm
OTHERsingle arm study
Interventions
After pulmonary vein isolation,20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.
Eligibility Criteria
You may qualify if:
- Diagnosed atrial fibrillation
- recurrence of symptomatic atrial fibrillation in spite of Antiarrhythmic drug use
- written informed consent
You may not qualify if:
- intracardiac thrombus
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yong Seog Ohlead
Study Sites (1)
Seoul st Mary's Hospital
Seoul, Seocho-Ku, 137-040, South Korea
Related Publications (1)
Kim JY, Kim SH, Song IG, Kim YR, Kim TS, Kim JH, Jang SW, Lee MY, Rho TH, Oh YS. Achievement of successful pulmonary vein isolation: methods of adenosine testing and incremental benefit of exit block. J Interv Card Electrophysiol. 2016 Sep;46(3):315-24. doi: 10.1007/s10840-016-0122-9. Epub 2016 Mar 9.
PMID: 26960977DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Y. Oh, director of clinical trial
- Organization
- Seoul St Mary's hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Yong seog Oh, MD
Seoul St. Mary's Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
August 14, 2013
First Posted
August 30, 2013
Study Start
November 1, 2012
Primary Completion
April 1, 2015
Study Completion
May 1, 2015
Last Updated
April 26, 2017
Results First Posted
April 13, 2016
Record last verified: 2017-04