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

Primary Purpose

Atrial Fibrillation, Persistent Common Pulmonary Vein

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Adenosine arm
Sponsored by
Yong Seog Oh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Pulmonary Vein Isolation, Adenosin effect, Atrial fibrillation ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • intracardiac thrombus
  • pregnancy

Sites / Locations

  • Seoul st Mary's Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

adenosine arm

Arm Description

single arm study

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

Full Information

First Posted
August 14, 2013
Last Updated
April 24, 2017
Sponsor
Yong Seog Oh
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1. Study Identification

Unique Protocol Identification Number
NCT01932112
Brief Title
Adenosine Effect on Persistent Pulmonary Vein Isolation Line Evaluation (APPLE Trial)
Acronym
APPLE
Official Title
Adenosine Effect on Persistent Pulmonary Vein Isolation Line Evaluation (APPLE Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yong Seog Oh

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Persistent Common Pulmonary Vein
Keywords
Pulmonary Vein Isolation, Adenosin effect, Atrial fibrillation ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
378 (Actual)

8. Arms, Groups, and Interventions

Arm Title
adenosine arm
Arm Type
Other
Arm Description
single arm study
Intervention Type
Drug
Intervention Name(s)
Adenosine arm
Other Intervention Name(s)
APPLE
Intervention Description
After pulmonary vein isolation,20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.
Primary Outcome Measure Information:
Title
Reconnection of Pulmonary Vein Electrogram After Adenosine Infusion
Description
After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.
Time Frame
5 minutes after IV adenosine
Secondary Outcome Measure Information:
Title
Atrial Fibrillation Recurrence
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed atrial fibrillation recurrence of symptomatic atrial fibrillation in spite of Antiarrhythmic drug use written informed consent Exclusion Criteria: intracardiac thrombus pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong seog Oh, MD
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul st Mary's Hospital
City
Seoul
State/Province
Seocho-Ku
ZIP/Postal Code
137-040
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
26960977
Citation
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.
Results Reference
derived

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

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