Clinical effects of the intra-operative radiofrequency ablation in patients with persistent or permanent atrial fibrillation and indication for an implantation of a heart valve prosthesis or coronary bypass surgery. The study will examine if and to what extent the quality of life and the use of medical care differs between patients with and without ablation. Furthermore, there will be thorough echocardiographical examinations of the heart to detect differences between the different treatment groups. The patients will be followed for one year after treatment.

Condition	Intervention
Persistent Atrial Fibrillation Permanent Atrial Fibrillation Mitral Valve Defect Tricuspid Valve Defect Aortic Valve Defect Coronary Artery Disease	Procedure: Intra-operative bipolar radiofrequency ablation of persistant and permanent atrial fibrillation

Further Study Details: 

Primary Outcomes: Quality of Life; Cost of Care
Secondary Outcomes: Atrial Fibrillation; Echo Parameters
Expected Total Enrollment:  100

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

Persistent Atrial Fibrillation Permanent Atrial Fibrillation Mitral Valve Defect Tricuspid Valve Defect Aortic Valve Defect Coronary Artery Disease

-

Exclusion Criteria:

• 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 (corornary 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00157807

Calin Vicol, Professor      089 7095 2358    calin.vicol@med.unu-muenchen.de

Germany, Baden Württemberg
      Kluinik für Herz-, Thorax- und Gefäßchirurgie, Lahr,  Baden Württemberg,  77933,  Germany
Germany, Bayern
      Klinikum der Universität Muenchen Großhadern Cardiac Surgery, München,  Bayern,  81377,  Germany
Germany, Nordrhein-Westfalen
      Klinik für Herz- und Thoraxchirurgie, Bochum,  Nordrhein-Westfalen,  44789,  Germany
      Klinik und Poliklinik für Herzchirurgie der Rhein. Friedrich-Wilhelms-Universität Bonn, Bonn,  Nordrhein-Westfalen,  53105,  Germany
Germany, Sachsen
      Klinik für Herz- und Thoraxchirurgie der Martin-Luther-Universität Halle-Wittenberg, Halle,  Sachsen,  06120,  Germany

Study chairs or principal investigators

Calin Vicol, Professor,  Principal Investigator,  Klinikum der Universität München Großhadern Cardiac Surgery   

Study ID Numbers:  CEN_G_CS_1
Last Updated:  September 10, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00157807
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-13