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

Atrial Fibrillation Clinical Trial

— VATCAT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01319747
• Other study ID #: NL32865.044.10
• Secondary ID: 32865Dutch trial
• Status: Terminated
• Phase: N/A
• First received: March 21, 2011
• Last updated: July 6, 2016
• Start date: September 2010
• Est. completion date: November 2014

Study information

• Verified date: July 2016
• Source: Medisch Spectrum Twente
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 77
• Est. completion date: November 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Netherlands	Medisch Spectrum Twente	Enschede	OV

Sponsors (2)

Lead Sponsor	Collaborator
Medisch Spectrum Twente	Cardio Research Enschede BV

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes

External Links

•   Official dutch entry for VATCAT study