Status:
COMPLETED
Radiofrequency Ablation of Drivers of Atrial Fibrillation
Lead Sponsor:
Felipe Atienza
Collaborating Sponsors:
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to assess the value of ablation of high frequency sources following circumferential pulmonary veins isolation in patients with paroxysmal and persistent atrial fibrillatio...
Detailed Description
Atrial fibrillation (AF) is the most common arrhythmia in clinical practice, accounts for one-third of arrhythmia hospitalizations and is associated with an increased risk of stroke, heart failure, an...
Eligibility Criteria
Inclusion
- Patients age 18 or older.
- Patients with paroxysmal AF symptomatic and refractory to at least one antiarrhythmic medication.
- In patients with paroxysmal AF, at least one episode of AF must have been documented by ECG or Holter within 12 months of randomization in the trial.
- Patients with persistent AF defined as a sustained episode that had been present for more than seven days without intervening spontaneous episodes of sinus rhythm and that recurred within seven days after cardioversion.
- Patients with persistent AF must be on continuous anticoagulation with warfarin (INR 2-3) for\> 4 weeks prior to ablation. In patients with paroxysmal AF no continuous anticoagulation therapy with warfarin for \> 4 weeks prior to ablation will be needed provided a transesophageal echocardiogram performed prior to ablation exclude the presence of thrombi or other abnormalities that discourage performing the procedure.
- Patients must be able and willing to provide written informed consent to participate in the clinical trial.
Exclusion
- Patients with AF secondary to reversible causes.
- Patients with inadequate anticoagulation levels as defined in the inclusion criteria.
- Patients with left atrial thrombus, tumor, or another abnormality which precludes catheter introduction on TEE prior to the procedure.
- Patients with contraindications to systemic anticoagulation with heparin or coumadin.
- Patients who have previously undergone atrial fibrillation ablation, either by surgery or by percutaneous catheter.
- Patients with left atrial size \> 55 mm.
- Patients who are or may potentially be pregnant.
- Patients with hyperthyroidism or hypothyroidism.
- Current enrollment in another investigational drug or device study.
- Pacemaker or Implantable Cardioverter Defibrillator.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT00674401
Start Date
January 1 2009
End Date
May 1 2013
Last Update
September 24 2013
Active Locations (11)
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1
Hospital Juan Canalejo
A Coruña, A Coruña, Spain, 15006
2
Hospital Vall d'Hebron
Barcelona, Barcelona, Spain, 08035
3
Hospital de Basurto
Bilbao, Bilbao, Spain, 48013
4
Clínica San Sebastian
Bilbao, Bilbao, Spain, 48014