The objective of this study is to compare the efficacy of three different ablation strategies in patients with persistent AF: 1. PV antral isolation alone (PVAI) 2. PV antral isolation plus ablation of drivers (PVAI+drivers) 3. PV antral isolation plus isolation of posterior wall (PVAI+box) All three strategies will employ contemporary catheter ablation technology using more efficient open irrigated tip cooling and contact force sensing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
617
Standard PVI
Standard PVI + Ablation of drivers in LA and RA
Standard PVI + Electrical isolation of the posterior wall of the left atrium
Freedom from documented atrial arrhythmia ≥ 30 seconds at 18 months after one ablation procedure on or off antiarrhythmic medications (AAM).
Time frame: 18 months
Freedom from documented AF > 30 seconds at 18 months after one procedure on or off AAM
Time frame: 18 months
Freedom from documented AF > 30 seconds at 18 months after one or more procedures on or off AAM
Time frame: 18 months
Freedom from documented atrial arrhythmia > 30 seconds at 18 months after one or more procedures on or off AAM
Time frame: 18 months
Freedom from documented AF > 30 seconds at 18 months after one procedure off AAM
Time frame: 18 months
Freedom from documented atrial arrhythmia > 30 seconds at 18 months after one procedure off AAM
Time frame: 18 months
Freedom from documented AF > 30 seconds at 18 months after one or more procedures off AAM
Time frame: 18 months
Freedom from documented atrial arrhythmia > 30 seconds after one or more procedures off AAM
Time frame: 18 months
Freedom from documented symptomatic AF > 30 seconds at 18 months after one procedure on or off AAM
Time frame: 18 months
Freedom from documented symptomatic atrial arrhythmia > 30 seconds after one procedure on or off AAM
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Brigham & Women'S Hosptial Inc.
Boston, Massachusetts, United States
Canberra Heart Rhythm Foundation
Garran, Australian Capital Territory, Australia
Royal Adelaide Hospital and Cardiovascular Centre
Adelaide, Australia
Alfred Health
Melbourne, Australia
Royal Melbourne Hospital
Parkville, Australia
Medical University of Graz
Graz, Austria
Ordensklinikum Linz GmbH
Linz, Austria
OLV Hospital Aalst
Aalst, Belgium
Antwerp University Hospital (UZA)
Edegem, Belgium
AZ Sint-Jan
Ruddershove, Belgium
...and 22 more locations
Time frame: 18 months
Each of the above success measures stratified by CHA2DS2-VASc score
Time frame: 18 months
Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, phrenic nerve palsy, and death
Time frame: 18 months
Procedure duration
Time frame: 18 months
Fluoroscopy time (dose)
Time frame: 18 months
Radiofrequency time
Time frame: 18 months
Number of repeat procedures
Time frame: 18 months
Effect of each strategy on AF cycle length changes and AF termination
Time frame: 18 months
Correlation of acute AF termination on long-term procedural outcome
Time frame: 18 months
Quality of life measurements during follow-up using AFEQT questionnaire
AFEQT questionnaires will be used at baseline, 6, 12 and 18 months
Time frame: 6-12-18 months
Quality of life measurements during follow-up using SF12 questionnaires
SF36 questionnaires will be used at baseline, 6, 12 and 18 months
Time frame: 6-12-18 months
Change in AF burden post-ablation procedure (% of time in AF)
Time frame: 18 months