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

NCT ID: NCT01319747

Last Updated: 2024-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2014-11-30

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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Percutaneous therapy

Group Type ACTIVE_COMPARATOR

PVI

Intervention Type PROCEDURE

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.

VATS therapy

Group Type ACTIVE_COMPARATOR

VATS-PVI

Intervention Type PROCEDURE

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.

Interventions

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PVI

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.

Intervention Type PROCEDURE

VATS-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.

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medisch Spectrum Twente

OTHER

Sponsor Role lead

Responsible Party

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B. Oude Velthuis

B. Oude Velthuis MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marcoen Scholten, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Medisch Spectrum Twente

Locations

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Medisch Spectrum Twente

Enschede, Overijssel, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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32865

Identifier Type: OTHER

Identifier Source: secondary_id

Dutch trial register entry

Identifier Type: REGISTRY

Identifier Source: secondary_id

NL32865.044.10

Identifier Type: -

Identifier Source: org_study_id

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