Phase 3
N=378
Adenosine Effect on Persistent Pulmonary Vein Isolation Line Evaluation (APPLE Trial)
Atrial Fibrillation · Persistent Common Pulmonary Vein
Bottom Line
View on ClinicalTrials.gov: NCT01932112 ↗Enrolled (actual)
378
Serious AEs
0.5%
Results posted
Apr 2016
Primary outcome: Primary: Reconnection of Pulmonary Vein Electrogram After Adenosine Infusion — 92 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Adenosine arm (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yong Seog Oh
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reconnection of Pulmonary Vein Electrogram After Adenosine Infusion |
92 | — |
| SECONDARY Atrial Fibrillation Recurrence |
— | — |
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
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
Data sourced from ClinicalTrials.gov (NCT01932112). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.