The purpose of this study is to determine the feasability of a new epicardial and minimal invasive ablation technique of the left atrium isolating the pulmonary veins for prevention of atrial fibrillation recurrences in patients with antiarrhythmic drug refractory lone atrial fibrillation.
Atrial fibrillation is a major health problem.Despite adequate treatment of underlying heart disease, rhythm control is unsuccessful in almost half of patients, also in patients with lone atrial fibrillation.If patients remain highly symptomatic, a non-pharmacological approach may be considered including pulmonary vein isolation and Cox maze III surgery. Maze III surgery has high succes rates, however it includes major cardiac surgery with substantial risk of complications. New surgical strategies for symptomatic lone atrial fibrillation focus on minimal invasive off-pump procedures omitting cardiopulmonary bypass (and thus lowering the complication rate), while taking advantage of an easier approach to the ablation site and a shorter procedure time. Epicardial surgical ablation isolating pulmonary veins by high intensity focused ultrasound performed off-pump by Video Assisted Thoracic Surgery (VATS)may be a promising treatment option. In this pilot study, we aim to study the feasibility of this new surgical ablation approach in patients with lone atrial fibrillation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
epicardial ablation using HIFU
University Medical Center Groningen
Groningen, Provincie Groningen, Netherlands
sinus rhythm at end of follow-up (6 months)
Time frame: 6 months
absence of permanent atrial fibrillation at end of follow-up
Time frame: 6 months
absence of any symptomatic atrial fibrillation
Time frame: 6 months
atrial volume and contraction at end of follow-up
Time frame: 6 months
left ventricular diameters and function at end of follow-up
Time frame: 6 months
thromboembolism
Time frame: 6 months
pulmonary vein stenosis
Time frame: 6 months
immediate postoperative complications (and related sequelae)
Time frame: directly post-operative
surgical procedure time and total epicardial ablation time
Time frame: directly post-operative
any pacemaker implantation
Time frame: 6 months
mortality
Time frame: 6 months
bleeding
Time frame: 6 months
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hospitalization for heart failure
Time frame: 6 months
antiarrhythmic drugs during follow-up
Time frame: 6 months
electrical cardioversions during follow-up
Time frame: 6 months
re-ablations
Time frame: 6 months
syncope
Time frame: 6 months
quality of life and specific arrhythmia symptoms
Time frame: 6 months