Atrial Fibrillation, Catheter Ablation
Conditions
Keywords
Atrial fibrillation, Complex fractionated electrograms, CFAE
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.
Interventions
PROCEDUREAdditional 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.
PROCEDUREStandard 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.
Sponsors
Fundacio Clinic Barcelona
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from atrial arrhythmias without antiarrhythmic drugs | 1-year follow-up |
Secondary
| Measure | Time frame |
|---|---|
| Freedom form atrial arrhythmias with or without antiarrhythmic drugs | 1-year follow-up |
| Presence of any complications in the acute phase or during follow-up | 1-year follow-up |
| Freedom from atypical atria flutter | 1-year follow-up |
| Increase in radioscopy time and radiofrequency application time | 1-year follow-up |
Countries
Spain
Outcome results
None listed