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Benefit of Left Atrial Roof Ablation in Paroxysmal Atrial Fibrillation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01203241
First Posted: September 16, 2010
Last Update Posted: December 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Josep Lluis Mont Girbau, Hospital Clinic of Barcelona
  Purpose
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.

Condition Intervention Phase
Drug-refractory Paroxysmal Atrial Fibrillation Procedure: Pulmonary vein encircling Procedure: Pulmonary vein encircling plus roof ablation Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Josep Lluis Mont Girbau, Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Freedom from atrial arrhythmias without antiarrhythmic drugs [ Time Frame: 1-year follow-up ]

Secondary Outcome Measures:
  • Freedom from atrial arrhythmias with or without antiarrhythmic drugs [ Time Frame: 1-year follow-up ]
  • Presence of any complications in the acute phase or during follow-up [ Time Frame: 1-year follow-up ]

Enrollment: 120
Study Start Date: June 2009
Study Completion Date: December 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional ablation
Pulmonary vein encircling by performing continuous radiofrequency lesions surrounding each ipsilateral pulmonary vein antrum
Procedure: Pulmonary vein encircling
Pulmonary vein encircling by performing continuous radiofrequency lesions surrounding each ipsilateral pulmonary vein antrum
Active Comparator: Conventional ablation plus left atrial roof ablation
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.
Procedure: Pulmonary vein encircling plus roof ablation
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.

  Eligibility

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01203241


Locations
Spain
Hospital Clinic Universitari
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Josep Lluis Mont Girbau, Head of the Arrhythmia Unit, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01203241     History of Changes
Other Study ID Numbers: LARA-PAF
First Submitted: September 15, 2010
First Posted: September 16, 2010
Last Update Posted: December 12, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes