Video-Assisted Thoracoscopic Pulmonary Vein Isolation Versus Percutaneous Catheter Ablation in Atrial Fibrillation Trial

Study Overview
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Brief Summary
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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.

Official Title
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Video-Assisted Thoracoscopic Pulmonary Vein Isolation Versus Percutaneous Catheter Ablation in Atrial Fibrillation Trial

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: PVI
* Procedure: VATS-PVI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Percutaneous therapy<br> | Procedure: PVI<br>* 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.<br>|
| Active Comparator: VATS therapy<br> | Procedure: VATS-PVI<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial, fibrillation, pvi, vats, ablation