Video-Assisted Thoracoscopic Pulmonary Vein Isolation Versus Percutaneous Catheter Ablation in Atrial Fibrillation Trial
NCT ID: NCT01319747
Last Updated: 2024-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
77 participants
INTERVENTIONAL
2010-09-30
2014-11-30
Brief Summary
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The investigators want to compare the effectiveness of PVI and VATS-PVI. Secondary objectives are to compare the duration of hospitalization, quality of Life, cost and to compare the satisfaction of the patients.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Percutaneous therapy
PVI
For catheter ablation, we used irrigated 4mm RF-ablation catheters, at a maximum power of 30-35Watt, an irrigation rate of 20 mL/min. PV isolation was performed by wide circumferential ablation, encircling all ipsilateral PVs.
VATS therapy
VATS-PVI
A bilateral video-assisted thoracoscopic (VATS) pulmonary vein isolation and left atrial appendage (LAA) excision is performed under general anaesthesia and double-lumen endotracheal ventilation.
Interventions
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PVI
For catheter ablation, we used irrigated 4mm RF-ablation catheters, at a maximum power of 30-35Watt, an irrigation rate of 20 mL/min. PV isolation was performed by wide circumferential ablation, encircling all ipsilateral PVs.
VATS-PVI
A bilateral video-assisted thoracoscopic (VATS) pulmonary vein isolation and left atrial appendage (LAA) excision is performed under general anaesthesia and double-lumen endotracheal ventilation.
Eligibility Criteria
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Inclusion Criteria
* Documented, symptomatic, episodes of paroxysmal or persistent AF
* During the last 6 months patients must have at least 2 documented episodes of AF, despite the use of at least 1 anti arrhythmic drug.
* Able of providing informed consent
Exclusion Criteria
* Unwillingness to use or contra-indications for vitamin K antagonists
* Severely enlarged left atrium (\>50 mm) on echocardiography
* Prior AF ablation or AF surgery
* Intracardiac thrombus
* Prior heart surgery or pulmonary disease hampering thoracoscopic surgery
18 Years
ALL
No
Sponsors
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Medisch Spectrum Twente
OTHER
Responsible Party
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B. Oude Velthuis
B. Oude Velthuis MD
Principal Investigators
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Marcoen Scholten, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Medisch Spectrum Twente
Locations
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Medisch Spectrum Twente
Enschede, Overijssel, Netherlands
Countries
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Other Identifiers
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32865
Identifier Type: OTHER
Identifier Source: secondary_id
Dutch trial register entry
Identifier Type: REGISTRY
Identifier Source: secondary_id
NL32865.044.10
Identifier Type: -
Identifier Source: org_study_id
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