Benefit of Left Atrial Roof Ablation in Paroxysmal Atrial Fibrillation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Josep Lluis Mont Girbau, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01203241
First received: September 15, 2010
Last updated: December 11, 2013
Last verified: December 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Freedom from atrial arrhythmias without antiarrhythmic drugs [ Time Frame: 1-year follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Freedom from atrial arrhythmias with or without antiarrhythmic drugs [ Time Frame: 1-year follow-up ] [ Designated as safety issue: No ]
  • Presence of any complications in the acute phase or during follow-up [ Time Frame: 1-year follow-up ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01203241

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

No publications provided

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
Study First Received: September 15, 2010
Last Updated: December 11, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

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

ClinicalTrials.gov processed this record on September 29, 2014