Benefit of Complex Fractionated Atrial Electrograms Elimination in Atrial Fibrillation Ablation
NCT ID: NCT00873067
Last Updated: 2014-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
142 participants
INTERVENTIONAL
2009-01-31
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ACVP plus roof line
Standard procedure for atrial fibrillation ablation, including pulmonary vein isolation plus roof line ablation. All ablation lines will be tested.
Standard atrial fibrillation ablation procedure
Standard procedure for persistent atrial fibrillation including circumferential pulmonary vein ablation and roof line, both being tested. No other lines or lesions will be performed.
Additional CFAEs ablation
Atrial fibrillation ablation with pulmonary vein ablation and roof line. In addition, complex fractionated atrial electrograms ablation will be performed, lasting at most 30 minutes.
Additional Complex Fractionated Electrograms ablation
Atrial fibrillation ablation with pulmonary vein ablation and roof line. In addition, complex fractionated atrial electrograms ablation will be performed, lasting at most 30 minutes.
Interventions
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Additional Complex Fractionated Electrograms ablation
Atrial fibrillation ablation with pulmonary vein ablation and roof line. In addition, complex fractionated atrial electrograms ablation will be performed, lasting at most 30 minutes.
Standard atrial fibrillation ablation procedure
Standard procedure for persistent atrial fibrillation including circumferential pulmonary vein ablation and roof line, both being tested. No other lines or lesions will be performed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presence of atrial fibrillation at the beginning of the procedure
Exclusion Criteria
* Persistent long-lasting or non-defined duration atrial fibrillation
* Hypertrophic myocardiopathy
* 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
* Contraindication to anticoagulation
* 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
* Any cause that contraindicate ablation procedure or antiarrhythmic drug
18 Years
70 Years
ALL
No
Sponsors
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Fundacio Clinic Barcelona
OTHER
Hospital Clinic of Barcelona
OTHER
Responsible Party
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Josep Lluis Mont Girbau
Head of the Arrhythmia Unit
Principal Investigators
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Lluís Mont, MD
Role: STUDY_CHAIR
Hospital Clinic Universitary de Barcelona
Elena Arbelo, MD, PhD
Role: STUDY_DIRECTOR
Hospital Clínic Universitari de Barcelona
Locations
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Hospital Clinic Universitari de Barcelona
Barcelona, Barcelona, Spain
Countries
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Other Identifiers
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HCP/08/207-4495-CFAE
Identifier Type: -
Identifier Source: org_study_id
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