This study will compare efficacy and safety of pulmonary vein isolation using a cryoballoon catheter versus a radiofrequency ablation with a contact force sensing catheter for treatment of patients with persistent or longstanding persistent atrial fibrillation.
The purpose of this randomized clinical trial is to compare the efficacy and safety of pulmonary vein isolation with either the second generation cryoballoon (Arctic Front Advance™) or a radiofrequency ablation technique with an irrigated ablation catheter (TactiCath™ Quartz) . A total of 128 patients with persistent or longstanding persistent atrial fibrillation will be randomized for either radiofrequency or cryoballoon ablation treatment. With both techniques, pulmonary vein isolation will be performed and confirmed by a circular mapping catheter. The primary endpoint is freedom of any atrial arrhythmia recurrence at 12 months.Treatment success will be evaluated by using 12-lead electrocardiography and 7-day Holter recording.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
101
Device: Arctic Front Advance™ cardiac cryoablation catheter system.
Device: TactiCath™ Quartz irrigated ablation catheter (St. Jude Medical) with aid of 3-D mapping system (EnSite Precision, St. Jude Medical).
Haukeland University Hospital
Bergen, Norway
University Hospital of North Norway
Tromsø, Norway
St Olavs Hospital
Trondheim, Norway
The freedom of any atrial arrhythmias at 12 months.
The primary endpoint is freedom of any atrial arrhythmias at 12 months (at least one episode of atrial fibrillation, or atrial flutter or atrial tachycardia with a duration \> 30 seconds documented by 7-day Holter ECG, or any other printed ECG recording).
Time frame: 12 months
Procedure duration
Procedure duration documented
Time frame: 12 months
Fluoroscopy time
Fluoroscopy time documented
Time frame: 12 months
Ablation time
Ablation time documented
Time frame: 12 months
Quality of life - Short Form (SF-36) Heath Survey
Short Form (SF-36) Heath Survey filled in by patients.
Time frame: 12 months.
Quality of life affected by atrial fibrillation.
The Atrial Fibrillation Effect on Quality-of-life (AFEQT) questionnaire will be filled in by patients.
Time frame: 12 months.
Admittance to hospital or emergency services due to symptoms caused by documented atrial arrhythmias.
Hospitalization after the procedre
Time frame: 12 months.
The burden of atrial fibrillation
Total duration of atrial fibrillation recorded by 7-day Holter.
Time frame: 12 months.
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The occurrence of documented left atrial tachycardia and typical or atypical atrial flutter.
Atrial tachycardia or atrial flutter recorded by all types of ECG
Time frame: 12 months.
Symptoms related to atrial fibrillation.
Symptoms related to atrial fibrillation documented
Time frame: 12 months.
Serious adverse events.
Serious adverse events documented
Time frame: 12 months.