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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


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
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