Status:
WITHDRAWN
A Prospective Multi Centre Trial on Bipolar Radiofrequency Ablation of Atrial Fibrillation
Lead Sponsor:
Norwegian University of Science and Technology
Collaborating Sponsors:
St. Olavs Hospital
Oslo University Hospital
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The study is a prospective multi-centre study to investigate the effect of a new bipolar ablation strategy of the left atrium in patients with paroxysmal or permanent atrial fibrillation over time.
Detailed Description
Atrial fibrillation (AF) is the most common persistent arrhythmia, prevalent in about 6% of the population over 65 years of age. AF reduces the quality of life and increases mortality. AF is particula...
Eligibility Criteria
Inclusion
- referred for elective heart surgery with extracorporeal circulation
- suffers from AF for more than 6 months but less than 7 years
- aged between 18 and 80 years
- ejection fraction above 30 %
Exclusion
- Reoperations
- NYHA class IV
- Ischemic mitral incompetence
- Creatinine \> 140
- Transmural myocardial infarction \< 4 weeks
- Endocarditis
- Serious peripheral vascular disease
- Pregnancy or breast-feeding
- Drug addiction
- Size of left atrium \> 60 mm in preoperative echo-doppler investigation.
- Disease or other condition when the patient is unable to understand the objectives and the scope of the study.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00184249
Start Date
June 1 2005
End Date
June 1 2012
Last Update
March 20 2015
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