Atrial Fibrillation
Conditions
Keywords
atrial, fibrillation, pvi, vats, ablation
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.
Interventions
PROCEDUREPVI
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.
PROCEDUREVATS-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.
Sponsors
Medisch Spectrum Twente
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of AF | 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
| Measure | Time frame | Description |
|---|---|---|
| Treatment impact | 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. |
Countries
Netherlands
Outcome results
None listed