210
Participants
Start Date
February 26, 2018
Primary Completion Date
May 30, 2022
Study Completion Date
June 30, 2022
Pulmonary vein isolation using CLOSE protocol
'CLOSE' protocol: Ablation index \> 400 at the posterior wall (reduce to 300 if esophagus temperature rise), ablation index \> 550 at the anterior wall, and inter-lesion distance \< 6.0mm
Antiarrhythmic drug therapy (ADT)
"During the first 3 months after PVI, patients continue oral anticoagulants and antiarrhythmic drug therapy (ADT). ADT is a continuation (or restart) of previously ineffective Class IC and III ADT. At the time of discharge, dosage is optimized according to the 2016 ESC guidelines on AF management.~Preferred dosages:~Flecainide: Tambocor or Flecainide EG 100mg b.i.d., Apocard R 100 to 200mg overdose (OD) Propafenone: Rytmonorm or Propafenone EG 300 mg b.i.d., except 225 mg b.i.d. if ≥70 years or \<70 kg Sotalol: Sotalex or Sotalol EG 80mg b.i.d., Except 80mg t.i.d. if men \< 70 years, Cr \<1.5mg/dl, \>70kg, except 80 mg OD if female \>70 years or Cr \>1.2mg/dl~In case of amiodarone intake before PVI, amiodarone is switched to sotalol or class IC ADT."
AZ Sint-Jan Hospital, Bruges
Medical University of Graz, Graz
Onze-Lieve-Vrouwziekenhuis Aalst, Aalst
ZNA Middelheim, Antwerp
Ziekenhuis Oost-Limburg, Genk
Jessa Ziekenhuis Hasselt, Hasselt
Gentofte Hospital, Gentofte Municipality
Hospital Universitari Germans Trias, Barcelona
Luzerner Kantonsspital, Lucerne
Biosense Webster, Inc.
INDUSTRY
AZ Sint-Jan AV
OTHER