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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
152
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
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
OLV Hospital
Aalst, Belgium
AZ St Jan
Bruges, Belgium
Efficacy as measured by freedom of arrhythmia recurrence
Arrhythmia recurrence rate at 1 year post ablation (9 months post randomization)
Time frame: 9 months
Safety as measured by drug discontinuation
Number of participants with any adverse events at 1 year post ablation (9 months post randomization) leading to drug discontinuation
Time frame: 9 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.