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Trial record 3 of 1177 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

Tracking Information
First Submitted Date  ICMJE August 14, 2013
First Posted Date  ICMJE August 30, 2013
Results First Submitted Date  ICMJE May 23, 2015
Results First Posted Date  ICMJE April 13, 2016
Last Update Posted Date April 26, 2017
Study Start Date  ICMJE November 2012
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 26, 2013)
Reconnection of Pulmonary Vein Electrogram After Adenosine Infusion [ Time Frame: 5 minutes after IV adenosine ]
After pulmonary vein isolation, 12mg Iv adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.
Change History Complete list of historical versions of study NCT01932112 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2013)
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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adenosine Effect on Persistent Pulmonary Vein Isolation Line Evaluation (APPLE Trial)
Official Title  ICMJE Adenosine Effect on Persistent Pulmonary Vein Isolation Line Evaluation (APPLE Trial)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Atrial Fibrillation
  • Persistent Common Pulmonary Vein
Intervention  ICMJE Drug: Adenosine arm
After pulmonary vein isolation,20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.
Other Name: APPLE
Study Arms  ICMJE adenosine arm
single arm study
Intervention: Drug: Adenosine arm
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 14, 2016)
378
Original Estimated Enrollment  ICMJE
 (submitted: August 26, 2013)
400
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • intracardiac thrombus
  • pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01932112
Other Study ID Numbers  ICMJE APPLE
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yong Seog Oh, Seoul St. Mary's Hospital
Study Sponsor  ICMJE Yong Seog Oh
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yong seog Oh, MD Seoul St. Mary's Hospital
PRS Account Seoul St. Mary's Hospital
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP