Video-Assisted Thoracoscopic Pulmonary Vein Isolation Versus Percutaneous Catheter Ablation in Atrial Fibrillation Trial (VATCAT)
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|ClinicalTrials.gov Identifier: NCT01319747|
Recruitment Status : Terminated (Inclusion rate insufficient)
First Posted : March 22, 2011
Last Update Posted : July 7, 2016
Recent studies demonstrated that radiofrequency isolation of the pulmonary veins (PVI) and surgically video assisted thorascopic pulmonary vein isolation (VATS-PVI) are acceptable or even superior alternatives to antiarrhythmic drug therapy in patients with symptomatically paroxysmal atrial fibrillation (AF). However, data comparing effectiveness in both interventions are limited.
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.
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Procedure: PVI Procedure: VATS-PVI||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||77 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Video-Assisted Thoracoscopic Pulmonary Vein Isolation Versus Percutaneous Catheter Ablation in Atrial Fibrillation Trial|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2014|
|Active Comparator: Percutaneous therapy||
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.
|Active Comparator: VATS therapy||
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.
- Recurrence of AF [ Time Frame: one year ]The percentage of patients without a recurrence of AF, without antiarrhythmic drugs (AADs), within a follow-up period of at least 12 months after a stabilisation period of 90 days after the initial procedure. An episode of AF is defined as an episode of at least 30 seconds duration.
- Treatment impact [ Time Frame: one year ]Secondary objectives include the duration and cost of hospitalization, discomfort during admission, assessment and experienced AF burden during follow-up of procedural impact on the patient and time to recurrence after intervention. A complication register will also be kept.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01319747
|Medisch Spectrum Twente|
|Enschede, OV, Netherlands, 7500KA|
|Principal Investigator:||Marcoen Scholten, MD PhD||Medisch Spectrum Twente|