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Benefit of Left Atrial Roof Ablation in Paroxysmal Atrial Fibrillation

Primary Purpose

Drug-refractory Paroxysmal Atrial Fibrillation

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Pulmonary vein encircling
Pulmonary vein encircling plus roof ablation
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug-refractory Paroxysmal Atrial Fibrillation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Clinic Universitari

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Conventional ablation

Conventional ablation plus left atrial roof ablation

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Freedom from atrial arrhythmias without antiarrhythmic drugs

Secondary Outcome Measures

Freedom from atrial arrhythmias with or without antiarrhythmic drugs
Presence of any complications in the acute phase or during follow-up

Full Information

First Posted
September 15, 2010
Last Updated
December 11, 2013
Sponsor
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT01203241
Brief Title
Benefit of Left Atrial Roof Ablation in Paroxysmal Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug-refractory Paroxysmal Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional ablation
Arm Type
Active Comparator
Arm Description
Pulmonary vein encircling by performing continuous radiofrequency lesions surrounding each ipsilateral pulmonary vein antrum
Arm Title
Conventional ablation plus left atrial roof ablation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Pulmonary vein encircling
Intervention Description
Pulmonary vein encircling by performing continuous radiofrequency lesions surrounding each ipsilateral pulmonary vein antrum
Intervention Type
Procedure
Intervention Name(s)
Pulmonary vein encircling plus roof ablation
Intervention Description
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 Outcome Measure Information:
Title
Freedom from atrial arrhythmias without antiarrhythmic drugs
Time Frame
1-year follow-up
Secondary Outcome Measure Information:
Title
Freedom from atrial arrhythmias with or without antiarrhythmic drugs
Time Frame
1-year follow-up
Title
Presence of any complications in the acute phase or during follow-up
Time Frame
1-year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hospital Clinic Universitari
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
25193295
Citation
Arbelo E, Guiu E, Ramos P, Bisbal F, Borras R, Andreu D, Tolosana JM, Berruezo A, Brugada J, Mont L. Benefit of left atrial roof linear ablation in paroxysmal atrial fibrillation: a prospective, randomized study. J Am Heart Assoc. 2014 Sep 5;3(5):e000877. doi: 10.1161/JAHA.114.000877.
Results Reference
derived

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Benefit of Left Atrial Roof Ablation in Paroxysmal Atrial Fibrillation

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