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Atrial Fibrillation: Ablation or Surgical Treatment II: FAST II

NCT01336075 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2014-01-03

No results posted yet for this study

Summary

The purpose of this study is to compare two invasive treatments of symptomatic paroxysmal atrial fibrillation: Percutaneous radiofrequency catheter ablation and mini invasive thoracoscopic radiofrequency ablation in patients referred for a first time invasive treatment for atrial fibrillation.

The hypothesis is, that mini invasive thoracoscopic radiofrequency ablation as a first time invasive treatment is more effective compared to a percutaneous catheter based technique in patients with symptomatic paroxysmal atrial fibrillation refractory or intolerant to at least one antiarrhythmic drug.

Conditions

  • Paroxysmal Atrial Fibrillation.

Interventions

PROCEDURE

Percutaneous radiofrequency catheter ablation

Percutaneous radiofrequency catheter ablation around the rights and lefts pulmonary veins, with complete circumferential ablation.

PROCEDURE

Mini invasive thoracoscopic radiofrequency ablation

Video-assisted thoracoscopic approach for electrical isolation of the pulmonary veins bilaterally and left atrial appendage excision or exclusion.

Sponsors & Collaborators

  • St. Antonius Hospital

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • Aalborg University Hospital

    lead OTHER

Principal Investigators

  • Henrik Vadmann, MD · Aalborg University Hospital

  • Sam Riahi, MD, PhD · Aalborg University Hospital

  • Jan Jesper Andreasen, MD, PhD · Aalborg University Hospital

  • Søren Hjortshøj, MD, PhD · Aalborg University Hospital

  • Alaaddin Yilmaz, MD · St. Antonius Hospital

  • Lucas Boersma, MD, PhD · St. Antonius Hospital

  • Axel Brandes, MD, FESC · Odense Universityhospital

  • Peter Pallesen, MD · Odense Universityhospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Denmark
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01336075 on ClinicalTrials.gov