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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ablation of pulmonary veins by video assisted thoracic surgery | Procedure | epicardial ablation using HIFU |
|
| Measure | Description | Time Frame |
|---|---|---|
| sinus rhythm at end of follow-up (6 months) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| absence of permanent atrial fibrillation at end of follow-up | 6 months | |
| absence of any symptomatic atrial fibrillation | 6 months | |
| atrial volume and contraction at end of follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isabelle C. Vam Gelder, MD | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Groningen | Provincie Groningen | 9700 RB | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19812047 | Derived | Klinkenberg TJ, Ahmed S, Ten Hagen A, Wiesfeld AC, Tan ES, Zijlstra F, Van Gelder IC. Feasibility and outcome of epicardial pulmonary vein isolation for lone atrial fibrillation using minimal invasive surgery and high intensity focused ultrasound. Europace. 2009 Dec;11(12):1624-31. doi: 10.1093/europace/eup299. Epub 2009 Oct 6. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| 6 months |
| left ventricular diameters and function at end of follow-up | 6 months |
| thromboembolism | 6 months |
| pulmonary vein stenosis | 6 months |
| immediate postoperative complications (and related sequelae) | directly post-operative |
| surgical procedure time and total epicardial ablation time | directly post-operative |
| any pacemaker implantation | 6 months |
| mortality | 6 months |
| bleeding | 6 months |
| hospitalization for heart failure | 6 months |
| antiarrhythmic drugs during follow-up | 6 months |
| electrical cardioversions during follow-up | 6 months |
| re-ablations | 6 months |
| syncope | 6 months |
| quality of life and specific arrhythmia symptoms | 6 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |