Status:
COMPLETED
Benefit of Complex Fractionated Atrial Electrograms Elimination in Atrial Fibrillation Ablation
Lead Sponsor:
Hospital Clinic of Barcelona
Collaborating Sponsors:
Fundacio Clinic Barcelona
Conditions:
Atrial Fibrillation
Catheter Ablation
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The aim of this study is to evaluate whether performing complex fractionated atrial electrograms ablation improves outcomes in persistent or atrial fibrillation ablation.
Eligibility Criteria
Inclusion
- Patients with persistent (more than 7 days, or less than 7 days needing pharmacologic or electric cardioversion)
- Presence of atrial fibrillation at the beginning of the procedure
Exclusion
- Hypo or hyperthyroidism
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT00873067
Start Date
January 1 2009
End Date
September 1 2013
Last Update
February 27 2014
Active Locations (1)
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1
Hospital Clinic Universitari de Barcelona
Barcelona, Barcelona, Spain, 08036