Status:
COMPLETED
Randomized Trial of Two Different Strategies to Treat Paroxysmal Atrial Fibrillation
Lead Sponsor:
Atrial Fibrillation Network
Collaborating Sponsors:
C. R. Bard
Biosense Webster, Inc.
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
50-85 years
Phase:
NA
Brief Summary
The purpose of this study is to investigate the significance of complete versus incomplete electrical isolation of pulmonary veins by radiofrequency-induced linear lesions in patients with paroxysmal ...
Detailed Description
Atrial fibrillation can be cured by elimination of triggering events such as atrial extrasystoles originating from the pulmonary veins (PV) by selective or linear radiofrequency current applications. ...
Eligibility Criteria
Inclusion
- Idiopathic paroxysmal symptomatic atrial fibrillation refractory to antiarrhythmic therapy
- Age 50 - 85 years
- Patient willing to participate in randomized trial and an invasive follow-up at month 3 (-6)
- Structural normal heart
- Patient willing and able to participate in 12 months follow-up period
- ECG documentation of atrial fibrillation (ECG, Holter, event recorders, etc) for at least one AF event in the prior year (related to symptomatic or asymptomatic episodes) with an average number of one episode per month
- Written informed consent of the patient
Exclusion
- Patients who have had previous pulmonary vein ablation procedures Patients with atrial fibrillation secondary to a reversible cause
- Known presence of intracardiac or other thrombi
- Evidence of obstructive lung disease requiring bronchodilator therapy
- Pregnant females or those of child bearing potential who have not had a negative pregnancy test within 48 hours before treatment.
- Other medical illness (i.e. cancer, congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the data interpretation or is associated with limited life-expectancy (i.e., less than one year)
- History of bleeding diathesis or suspected pro-coagulant state contraindication to anticoagulation therapy
- Hyperthyroidism or hypothyroidism manifested clinically and in laboratory tests (TSH, T3, T4)
- Participation in a clinical trial within the last 30 days. Simultaneous participation in a registry (e.g. project AB1 of the AFNET) is permitted.
- Drug addiction or chronic alcohol abuse
- Legal incapacity, or other circumstances which would prevent the patient from understanding the aim, nature or extent of the clinical trial
- Evidence of an uncooperative attitude
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT00293943
Start Date
February 1 2006
End Date
August 1 2010
Last Update
September 10 2012
Active Locations (3)
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1
General Hospital St. Georg, Department of Cardiology
Hamburg, Germany, 20099
2
University Cardiac Center
Hamburg, Germany, 20246
3
University Hospital, Department of Cardiology
Münster, Germany, 48149