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

NCT ID: NCT01932112

Last Updated: 2017-04-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

378 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-05-31

Brief Summary

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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

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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.

Conditions

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Atrial Fibrillation Persistent Common Pulmonary Vein

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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adenosine arm

single arm study

Group Type OTHER

Adenosine arm

Intervention Type DRUG

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

Interventions

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Adenosine arm

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

Intervention Type DRUG

Other Intervention Names

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APPLE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* intracardiac thrombus
* pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yong Seog Oh

OTHER

Sponsor Role lead

Responsible Party

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Yong Seog Oh

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yong seog Oh, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital

Locations

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Seoul st Mary's Hospital

Seoul, Seocho-Ku, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 26960977 (View on PubMed)

Other Identifiers

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APPLE

Identifier Type: -

Identifier Source: org_study_id

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