Back to resultsVideo-Assisted Thoracoscopic Pulmonary Vein Isolation Versus Percutaneous Catheter Ablation in Atrial Fibrillation Trial (VATCAT)
Primary Purpose
Atrial Fibrillation
Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
PVI
VATS-PVI
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial, fibrillation, pvi, vats, ablation
Eligibility 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
Sites / Locations
- Medisch Spectrum Twente
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Percutaneous therapy
VATS therapy
Arm Description
Outcomes
Primary Outcome Measures
Recurrence of AF
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
Treatment impact
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.
Full Information
NCT ID
NCT01319747
First Posted
March 21, 2011
Last Updated
July 6, 2016
Sponsor
Medisch Spectrum Twente
Collaborators
Foundation of Cardiovascular Research and Education Enschede
1. Study Identification
Unique Protocol Identification Number
NCT01319747
Brief Title
Video-Assisted Thoracoscopic Pulmonary Vein Isolation Versus Percutaneous Catheter Ablation in Atrial Fibrillation Trial
Acronym
VATCAT
Official Title
Video-Assisted Thoracoscopic Pulmonary Vein Isolation Versus Percutaneous Catheter Ablation in Atrial Fibrillation Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Terminated
Why Stopped
Inclusion rate insufficient
Study Start Date
September 2010 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medisch Spectrum Twente
Collaborators
Foundation of Cardiovascular Research and Education Enschede
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial, fibrillation, pvi, vats, ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Percutaneous therapy
Arm Type
Active Comparator
Arm Title
VATS therapy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
PVI
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
VATS-PVI
Intervention Description
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 Measure Information:
Title
Recurrence of AF
Description
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.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Treatment impact
Description
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.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcoen Scholten, MD PhD
Organizational Affiliation
Medisch Spectrum Twente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medisch Spectrum Twente
City
Enschede
State/Province
OV
ZIP/Postal Code
7500KA
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Video-Assisted Thoracoscopic Pulmonary Vein Isolation Versus Percutaneous Catheter Ablation in Atrial Fibrillation Trial
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