The purpose of this clinical study is to assess the single procedure outcomes of using cryoballoon ablation without additional empirical lesions and/or complex fractionated electrogram (CFE) ablations for patients with early persistent atrial fibrillation (\<1 year from first diagnosis of persistent AF).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Subjects will wear holter monitors at baseline, 6 months and 12 months.
Hôpital Henri Mondor
Créteil, France
CHU de Grenoble
Grenoble, France
CHU de la Timone
Marseille, France
Single procedure success of cryoballoon ablation on patients with early persistent AF
12 month success will be defined as absence of adjudicated AF/atrial flutter/atrial tachyarrhythmias \>/= 30 seconds in duration from the end of the 90 day blanking period of the cryoballoon ablation procedure to at least 12 months after the cryoballoon ablation procedure. Only Arctic Front Advance catheters may be used to achieve the single procedure success and no additional empirical lesions and/or complex fractionated electrogram (CFE) ablations may be made. Additionally, subjects must not require any other intervention for AF following the index procedure. Right atrial flutter ablations and pharmacological and/or electrical cardioversion can be performed within the 90 day blanking period.
Time frame: 12 months
Acute procedural success of cryoballoon ablation on patients with early persistent AF
Acute procedural success is defined as: * Only Arctic Front Advance catheters used to achieve procedure success AND * All targeted pulmonary veins were isolated (minimally assessed for entrance block and, where assessable, exit block) AND * Sinus rhythm is restored at the end of the ablation procedure (with or without cardioversion)
Time frame: Post-procedure
Success of cryoballoon ablation on patients with early persistent AF (allowing for multiple procedures)
12 month success will be defined as absence of adjudicated AF/atrial flutter/atrial tachyarrhythmias \>/= 30 seconds in duration from the end of the 90 day blanking period of the cryoballoon ablation procedure to at least 12 months after the cryoballoon ablation procedure. Only Arctic Front Advance catheters may be used to achieve multiple procedure success and no additional empirical lesions and/or complex fractionated electrogram (CFE) ablations may be made. Additionally, subjects must not require any other intervention for AF. Right atrial flutter ablations and pharmacological and/or electrical cardioversion can be performed within the 90 day blanking period.
Time frame: 12 months
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CHU - Hôpitaux de Rouen
Rouen, France
Clinique Pasteur
Toulouse, France
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, Germany
Charite - Universitaetsmedizin
Berlin, Germany
Krankenhaus Porz am Rhein
Cologne, Germany
St. Vinzenz-Hospital
Cologne, Germany
Cardioangiologisches Centrum Bethanien
Frankfurt, Germany
...and 4 more locations
Sinus rhythm restoration being followed by chronic prevention of AF recurrence
Time frame: 12 months
Use of class I and class III antiarrhythmic drugs
Time frame: 12 months
Changes in quality of life measurements between baseline, 6 months and 12 months after procedure
Time frame: Baseline, 6 months, 12 months
Adverse events required to be collected during the study
Time frame: 12 months