Benefit of Left Atrial Roof Ablation in Paroxysmal Atrial Fibrillation

Drug-refractory Paroxysmal Atrial Fibrillation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01203241
• Other study ID #: LARA-PAF
• Status: Completed
• Phase: Phase 3
• First received: September 15, 2010
• Last updated: December 11, 2013
• Start date: June 2009
• Est. completion date: December 2012

Study information

• Verified date: December 2013
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Drug-refractory Paroxysmal Atrial Fibrillation

Intervention

Procedure:
• Pulmonary vein encircling
Pulmonary vein encircling by performing continuous radiofrequency lesions surrounding each ipsilateral pulmonary vein antrum
• 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.

Locations

Country	Name	City	State
Spain	Hospital Clinic Universitari	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from atrial arrhythmias without antiarrhythmic drugs		1-year follow-up	No
Secondary	Freedom from atrial arrhythmias with or without antiarrhythmic drugs		1-year follow-up	No
Secondary	Presence of any complications in the acute phase or during follow-up		1-year follow-up	Yes