N/A N=110 Randomized Treatment

A Study of the Effectiveness of Anti-Arrhythmic Medications After Atrial Fibrillation Ablation

Atrial Fibrillation

Bottom Line

View on ClinicalTrials.gov: NCT00408200 ↗

Enrolled (actual)

110

Serious AEs

0.0%

Results posted

Mar 2013

Primary outcome: Primary: Composite Endpoint: Atrial Arrhythmias Lasting >24 Hrs or Requiring Antiarrhythmic Drug Therapy; Need for Cardioversion/Repeat Ablation During the Study Period; Adverse Outcome/Intolerance of Antiarrhythmic Agent Requiring Cessation or Change of Drug — 24; 10 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: propafenone; flecainide; sotalol; dofetilide (Drug); Radiofrequency catheter ablation (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Pennsylvania
Primary completion: Apr 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Composite Endpoint: Atrial Arrhythmias Lasting >24 Hrs or Requiring Antiarrhythmic Drug Therapy; Need for Cardioversion/Repeat Ablation During the Study Period; Adverse Outcome/Intolerance of Antiarrhythmic Agent Requiring Cessation or Change of Drug	24; 10	—
SECONDARY Freedom From Atrial Arrhythmia at 6 Months Post Procedure.	39; 35	<0.05 sig

Summary

The purpose of this study is to examine the overall effectiveness of anti-arrhythmic medicines (to control heart rhythm) prescribed after an ablation procedure for atrial fibrillation.

Eligibility Criteria

Inclusion Criteria

Adult patients meeting ACC/AHA criteria for paroxysmal atrial fibrillation (episodes typically last no more than 7 days and are self-terminating)
Eligible for pulmonary vein isolation
Able to tolerate antiarrhythmic medication

Exclusion Criteria

Age 7 days and require cardioversion)
Antiarrhythmic treatment for indication other than atrial fibrillation
Contraindication or intolerance to all antiarrhythmic medications
Primary physician unwilling to withhold antiarrhythmic drugs for duration of the study
Failure to obtain informed consent

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00408200). 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.