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OpenTrials
Completed

NCT Number: NCT01203241

Benefit of Left Atrial Roof Ablation in Paroxysmal Atrial Fibrillation

The aim of the present study is to assess whether left atrial roof ablation adds any benefit in the arrhythmia-free probability after paroxysmal atrial fibrillation ablation.

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Key information

Conditions

Drug-refractory Paroxysmal Atrial Fibrillation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Clinic Universitari

Barcelona, 08036, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Drug-refractory paroxysmal atrial fibrillation

Exclusion criteria

  • Hypo or hyperthyroidism
  • Implantable defibrillation or pacemaker implanted
  • Moderate or severe mitral valve disease or mitral prosthetic valve
  • Ejection fraction less than 30%
  • Left atrial anteroposterior diameter more than 50 mm.
  • Previous atrial fibrillation ablation
  • Left atrium thrombus
  • Current infective disease or sepsis
  • Pregnant women
  • Current unstable angor
  • Acute myocardial infarction in last 3 months
  • Atrial fibrillation secondary to ionic disturbance, thyroids disease or secondary to any other reversible or non cardiovascular disease
  • Reduced expectancy of life (less than 12 months)
  • Patient participating in another clinical study that investigates a drug or device
  • Psychologically unstable patient or denies to give informed consent

Treatment and study plan

Pulmonary vein encircling

Procedure

Pulmonary vein encircling by performing continuous radiofrequency lesions surrounding each ipsilateral pulmonary vein antrum

Pulmonary vein encircling plus roof ablation

Procedure

Pulmonary vein encircling by performing continuous radiofrequency lesions surrounding each ipsilateral pulmonary vein antrum plus creation of a radiofrequency line joining contralateral superior pulmonary veins throughout the left atrial roof.

Primary outcomes

  1. Freedom from atrial arrhythmias without antiarrhythmic drugs

    Time frame: 1-year follow-up

Secondary outcomes

  1. Freedom from atrial arrhythmias with or without antiarrhythmic drugs

    Time frame: 1-year follow-up

  2. Presence of any complications in the acute phase or during follow-up

    Time frame: 1-year follow-up

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Sep 16, 2010
Registry last updated
Dec 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.