Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448656
Status:
COMPLETED
Last Update Posted:
2012-06-19
First Post:
2007-03-15
Brief Title:
Treatment of Atrial Fibrillation by Minimal Invasive Surgery
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Treatment of Atrial Fibrillation by Minimal Invasive Epicardial Pulmonary Vein Isolation The ABOLISH-AF Study
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ABOLISH-AF
Brief Summary:
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
Detailed Description:
Atrial fibrillation is a major health problemDespite adequate treatment of underlying heart disease rhythm control is unsuccessful in almost half of patients also in patients with lone atrial fibrillationIf 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 VATSmay 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None