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Trial record 3 of 1129 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

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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Persistent Common Pulmonary Vein Drug: Adenosine arm Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 378 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adenosine Effect on Persistent Pulmonary Vein Isolation Line Evaluation (APPLE Trial)
Study Start Date : November 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Adenosine

Arm Intervention/treatment
adenosine arm
single arm study
Drug: Adenosine arm
After pulmonary vein isolation,20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.
Other Name: APPLE




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01932112


Locations
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Korea, Republic of
Seoul st Mary's Hospital
Seoul, Seocho-Ku, Korea, Republic of, 137-040
Sponsors and Collaborators
Yong Seog Oh
Investigators
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Principal Investigator: Yong seog Oh, MD Seoul St. Mary's Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yong Seog Oh, MD, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT01932112     History of Changes
Other Study ID Numbers: APPLE
First Posted: August 30, 2013    Key Record Dates
Results First Posted: April 13, 2016
Last Update Posted: April 26, 2017
Last Verified: April 2017

Keywords provided by Yong Seog Oh, Seoul St. Mary's Hospital:
Pulmonary Vein Isolation
Adenosin effect
Atrial fibrillation ablation

Additional relevant MeSH terms:
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Adenosine
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action