NCT02475642

Pulmonary Vein Isolation With Versus Without Continued Antiarrhythmic Drug Treatment in Subjects With Recurrent Atrial Fibrillation

Pulmonary Vein Isolation With Versus Without Continued Antiarrhythmic Drug Treatment in Subjects With Recurrent Atrial Fibrillation: A Prospective 2-Centre Randomized Controlled Clinical Study (POWDER-AF)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: VZW Cardiovascular Research Center Aalst · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy and safety of PV isolation with continued antiarrhythmic drug treatment (PVI+ADT) to PV isolation without continued ADT (PVI-ADT) in patients undergoing treatment for symptomatic recurrent AF.

Detailed description

Subjects that underwent PV isolation for paroxysmal or non-longstanding persistent AF and are free of arrhythmia at the end of the 3-month blanking period while taking ADT. Eligible subjects who sign the study informed consent form will be randomized into one of two study arms: PVI+ADT Group: continue ADT through 9 months follow-up PVI-ADT Group: no ADT through 9 months follow up

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
OTHER	PVI-ADT	Discontinue antiarrhythmic drugs at randomisation (3 months post ablation). As per the eligibility criteria, all patients randomised are taking either Flecainide, Cibenzoline, Propafenon, Sotalol or Amiodarone. These are discontinued at the moment of randomisation in this arm
OTHER	PVI+ADT	Discontinue antiarrhythmic drugs 9 months after randomisation (12 months post ablation). As per the eligibility criteria, all patients randomised are taking either Flecainide, Cibenzoline, Propafenon, Sotalol or Amiodarone. These are continued in this arm until 9 months post randomisation at which point they are stopped

Timeline

• Start date: 2014-03-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2015-06-19
• Last updated: 2016-04-28

Locations

2 sites across 1 country: Belgium