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Benefit of Left Atrial Roof Ablation in Paroxysmal Atrial Fibrillation

This study is currently recruiting participants.
Verified September 2011 by Hospital Clinic of Barcelona
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: September 22, 2011
Last verified: September 2011
History of Changes
  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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 120
Study Start Date: June 2009
Estimated Study Completion Date: December 2012
Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01203241

Contacts
Contact: Lluis Mont, MD, PhD 0034932275551 lmont@clinic.ub.es

Locations
Spain
Hospital Clinic Universitari Recruiting
Barcelona, Spain, 08036
Contact: Lluis Mont, MD, PhD     00349322755551     lmont@clinic.ub.es    
Contact: Elena Arbelo, MD, PhD     +34932275551     earbelo@clinic.ub.es    
Principal Investigator: Lluis Mont, MD, PhD            
Principal Investigator: Elena Arbelo, MD, PhD            
Sub-Investigator: Antonio Berruezo, MD, PhD            
Sub-Investigator: José M Tolosana, MD            
Sub-Investigator: Esther Guiú, B Eng            
Sub-Investigator: David Andreu, B Eng            
Sub-Investigator: Roger Borras, B Sc            
Hospital Clinic Universitari Recruiting
Barcelona, Spain, 08036
Contact: Lluis Mont, MD, PhD     0034932275551     lmont@clinic.ub.es    
Contact: Elena Arbelo, MD, PhD     +34932275551     earbelo@clinic.ub.es    
Principal Investigator: Lluís Mont, MD, PhD            
Principal Investigator: Elena Arbelo, MD, PhD            
Sub-Investigator: Antonio Berruezo, MD, PhD            
Sub-Investigator: José M Tolosana, MD            
Sub-Investigator: Esther Guiú, B Eng            
Sub-Investigator: David Andreu, B Eng            
Sub-Investigator: Roger Borras, B Sc            
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: September 22, 2011
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 May 16, 2013