Pulmonary Vein Isolation With Versus Without Continued Antiarrhythmic Drugs in Persistent Atrial Fibrillation

NACompletedINTERVENTIONAL
Enrollment

210

Participants

Timeline

Start Date

February 26, 2018

Primary Completion Date

May 30, 2022

Study Completion Date

June 30, 2022

Conditions
Atrial Fibrillation
Interventions
OTHER

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

DRUG

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."

Trial Locations (9)

8000

AZ Sint-Jan Hospital, Bruges

Unknown

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

All Listed Sponsors
collaborator

Biosense Webster, Inc.

INDUSTRY

lead

AZ Sint-Jan AV

OTHER

NCT03437356 - Pulmonary Vein Isolation With Versus Without Continued Antiarrhythmic Drugs in Persistent Atrial Fibrillation | Biotech Hunter | Biotech Hunter