Status:
TERMINATED
Clinical and Economic Consequences of Left Atrial Bipolar Radiofrequency Ablation of Persistent and Permanent Atrial Fibrillation During Cardiac Surgery
Lead Sponsor:
Medtronic Cardiac Surgery
Collaborating Sponsors:
Medtronic
Conditions:
Atrial Fibrillation
Coronary Artery Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The clinical effects of intra-operative radiofrequency ablation in patients with persistent or permanent atrial fibrillation and an indication for an implantation of a heart valve prosthesis or corona...
Eligibility Criteria
Inclusion
- Persistent atrial fibrillation
- Permanent atrial fibrillation
- Mitral valve defect
- Tricuspid valve defect
- Aortic valve defect
- Coronary artery disease
Exclusion
- Pregnancy
- Age \< 18 or \> 75 Years
- Emergency surgery
- Left dominant coronary circulation (relative contraindication)
- Coronary arteries of the posterior wall without pathological findings: No inclusion
- Stenosis of the posterior wall vessels, supplied with a CABG (coronary artery bypass grafting): Inclusion possible
- Left ventricular ejection fraction \< 30%
- Size of the left atrium \> 7 cm
- Thrombosis of the left atrial appendage
- Leads in the coronary sinus
- Atrial flutter
- Infective endocarditis
- Reoperation
- Participation in other studies
- Life expectancy of less than 12 months
- Psychiatric disorders
- Hyperthyreosis
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00157807
Start Date
September 1 2005
End Date
August 1 2013
Last Update
May 8 2025
Active Locations (5)
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1
Klinik für Herz-, Thorax- und Gefäßchirurgie
Lahr, Baden-Wurttemberg, Germany, 77933
2
Klinikum der Universität Muenchen Großhadern Cardiac Surgery
München, Bavaria, Germany, 81377
3
Klinik für Herz- und Thoraxchirurgie
Bochum, North Rhine-Westphalia, Germany, 44789
4
Klinik und Poliklinik für Herzchirurgie der Rhein. Friedrich-Wilhelms-Universität Bonn
Bonn, North Rhine-Westphalia, Germany, 53105