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Video-Assisted Thoracoscopic pulmonary vein isolation versus percutaneous Catheter Ablation in atrial fibrillation Trial.


- candidate number8309
- NTR NumberNTR2455
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-aug-2010
- Secondary IDsNL32865.044.10 / 10218 ; CCMO / METC Medisch Spectrum Twente
- Public TitleVideo-Assisted Thoracoscopic pulmonary vein isolation versus percutaneous Catheter Ablation in atrial fibrillation Trial.
- Scientific TitleVideo-Assisted Thoracoscopic pulmonary vein isolation versus percutaneous Catheter Ablation in atrial fibrillation Trial.
- ACRONYMVATCAT
- hypothesisThe primary hypothesis of the VATCAT trial is that PVI is superior to VATS-PVI in patients with symptomatic AF in terms of cardiovascular mortality and morbidity, QoL and cost.
- Healt Condition(s) or Problem(s) studiedAtrial Fibrillation
- Inclusion criteria1. Patients > 18 years of age;
2. Documented, symptomatic, episodes of paroxysmal or persistent AF;
3. 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;
4. Able of providing informed consent.
- Exclusion criteria1. Pregnancy;
2. Unwillingness to use or contra-indications for vitamin K antagonists;
3. Severely enlarged left atrium (>50 mm) on echocardiography;
4. Prior AF ablation or AF surgery;
5. Intracardiac thrombus;
6. Prior heart surgery or pulmonary disease hampering thoracoscopic surgery.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 9-aug-2010
- planned closingdate12-dec-2011
- Target number of participants150
- InterventionsPercutaneous catheter ablation (n=104) versus video-assisted epicardial ablation and left atrial appendage exclusion (n=52) in a 2:1 randomization.
- Primary outcomeThe percentage of patients without a recurrence of AF, without 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 outcomeSecondary 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.
- Timepoints3, 6 and 12 months.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES B. Oude Velthuis
- CONTACT for SCIENTIFIC QUERIES B. Oude Velthuis
- Sponsor/Initiator Medisch Spectrum Twente
- Funding
(Source(s) of Monetary or Material Support)
Medisch Spectrum Twente
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD4-aug-2010 - 14-aug-2010


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