The purpose of this study is to evaluate the effectiveness of Pulmonary Vein Isolation (PVI) performed with the Arctic Front™ Advance Cardiac CryoAblation Catheter System as first-line therapy in comparison with antiarrhythmic drugs (AAD) in patients with paroxysmal atrial fibrillation (AF).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
AAD therapy based on hospital clinical practice according to ESC Guidelines 2012
nstituto Cardiovascular de Buenos Aires
Buenos Aires, Argentina
Monash Medical Centre
Melbourne, Australia
Freedom from any atrial arrhythmia recurrence
The primary endpoint is freedom from any atrial arrhythmia recurrence at 12 months (at least one episode of AF, atrial flutter or atrial tachycardia with a duration \> 30 seconds documented by 7 day Holter ECG or any other printed ECG recording following a blanking period or a dosing optimizing period of 3 months).
Time frame: 12 months
quality of life
The quality of life of the two arms measured by means of SF-36 Health Survey and Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaires will be compared at 12 months follow-up.
Time frame: 12 months
Hospital or emergency services accesses
Hospital or emergency services accesses due to symptoms caused by documented atrial arrhythmias will be compared in the two arms at 12 months follow-up.
Time frame: 12 Months
Freedom from occurrence of AF
Freedom from occurrence of AF (after 3 months blanking period) will be compared between the two arms at 12 months follow-up.
Time frame: 12 months
Freedom from occurrence of documented left atrial tachycardia and left atrial flutter
Freedom from occurrence of documented left atrial tachycardia and typical - or atypical left atrial flutter (after 3 months blanking period or AAD optimization period) will be compared between the two arms at 12 months follow-up.
Time frame: 12 months
Symptomatic palpitations burden
Symptomatic palpitations burden will be evaluated by mean of Patient's diary information and compared between the two arms at 12 months follow-up.
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Heart Rhythm Management Centre, UZ Brussels - VUB Brussel
Brussels, Belgium
Klinicki bolnicki centar Sestre Milosrdnice
Zagreb, Croatia
Klinicki bolnicki centar Sestre
Zagreb, Croatia
NCHU Amiens
Amiens, France
CHU Grenoble
Grenoble, France
CHU La Pitié
Paris, France
CHU Charles Nicolle
Rouen, France
Kerckhoff - Klinik
Bad Nauheim, Germany
...and 9 more locations
Time frame: 12 months
Severe adverse events incidence
Severe adverse events incidence will be compared between the two arms during the whole course of the study.
Time frame: 12 months
Freedom from persistent AF
Freedom from persistent AF (AF episode lasting longer than 7 days or interrupted by pharmacological or electrical cardioversion after 48h from the onset of the episode) will be compared between the two arms at 12 months follow-up.
Time frame: 12 months
Echocardiographic left atrial re-modelling
Echocardiographic left atrial parameters will be compared between the two arms at 6 and 12 months follow ups.
Time frame: 12 months
health care utilization
Frequency, type and associated cost of health care utilization and utility will be compared between the two arms at 12 months follow-up.
Time frame: 12 months