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

Phase 4

Completed

• Conditions: 10007593; minimaal invasieve interventie; atrial fibrillation; 10007521

• Registration Number: NL-OMON39516
• Lead Sponsor: Medisch Spectrum Twente

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 160

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p> The percentage of patients without a recurrence of AF, without AADs, within a<br /><br>follow-up period of at least 12 months after a stabilisation period of 90 days<br /><br>after the initial procedure. An episode of AF is defined as an episode of at<br /><br>least 30 seconds duration. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives include the duration and cost of hospitalization,<br /><br>discomfort during admission, assessment and experienced AF burden during<br /><br>follow-up of procedural impact on the patient and time to recurrence after<br /><br>intervention. A complication register will also be kept.</p><br>