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

NCT01319747 | Terminated

• 3 other identifiers: NL32865.044.1032865Dutch trial register entry
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

atrial; fibrillation; pvi; vats; ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Treatment impact

  one year

Study Arms (2)

Percutaneous therapy

ACTIVE COMPARATOR

Procedure: PVI

VATS therapy

ACTIVE COMPARATOR

Procedure: VATS-PVI

Interventions

PVI 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.

Percutaneous therapy

VATS-PVI 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.

VATS therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medisch Spectrum Twente: lead

Study Sites (1)

Medisch Spectrum Twente

Enschede, Overijssel, 7500KA, Netherlands

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marcoen Scholten, MD PhD

  Medisch Spectrum Twente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: B. Oude Velthuis MD

Study Record Dates

• First Submitted: March 21, 2011
• First Posted: March 22, 2011
• Study Start: September 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2014
• Last Updated: November 22, 2024

Record last verified: 2024-11

Locations

NL (1)