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

Not Applicable

Terminated

• Conditions: Atrial Fibrillation
• Interventions: Procedure: PVI; Procedure: VATS-PVI

• Registration Number: NCT01319747
• Lead Sponsor: Medisch Spectrum Twente

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-03-21
• Study First Submitted QC: 2011-03-21
• Study First Posted: 2011-03-22
• Primary Completion: 2013-11
• Study Completion: 2014-11
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 77

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: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Percutaneous therapy	PVI	-
VATS therapy	VATS-PVI	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Medisch Spectrum Twente; 🇳🇱 Enschede, OV, Netherlands