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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
Sponsor:
Collaborator:
Foundation of Cardiovascular Research and Education Enschede
Information provided by (Responsible Party):
B. Oude Velthuis, Medisch Spectrum Twente

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Percutaneous therapy Procedure: 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.

Active Comparator: VATS therapy Procedure: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients > 18 years of age
  • 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:

  • Pregnancy
  • 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

Information from the National Library of Medicine

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


Locations
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Netherlands
Medisch Spectrum Twente
Enschede, OV, Netherlands, 7500KA
Sponsors and Collaborators
Medisch Spectrum Twente
Foundation of Cardiovascular Research and Education Enschede
Investigators
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Principal Investigator: Marcoen Scholten, MD PhD Medisch Spectrum Twente
Additional Information:
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Responsible Party: B. Oude Velthuis, B. Oude Velthuis MD, Medisch Spectrum Twente
ClinicalTrials.gov Identifier: NCT01319747    
Other Study ID Numbers: NL32865.044.10
32865 ( Other Identifier: CCMO ABR Nummer )
Dutch trial register entry ( Registry Identifier: NTR2455 )
First Posted: March 22, 2011    Key Record Dates
Last Update Posted: July 7, 2016
Last Verified: July 2016
Keywords provided by B. Oude Velthuis, Medisch Spectrum Twente:
atrial
fibrillation
pvi
vats
ablation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes