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OpenTrials
Completed

NCT Number: NCT01932112

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

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Persistent Common Pulmonary Vein

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul st Mary's Hospital

Seoul, Seocho-Ku, 137-040, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • intracardiac thrombus
  • pregnancy

Treatment and study plan

Adenosine arm

Drug

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

Other names: APPLE

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Yong Seog Oh

Other

Registry information

Acronym: APPLE

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 30, 2013
Registry last updated
Apr 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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