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Clinical and Economic Consequences of Left Atrial Bipolar Radiofrequency Ablation of Persistent and Permanent Atrial Fibrillation During Cardiac Surgery

Not Applicable
Terminated
Conditions
Atrial Fibrillation
Coronary Artery Disease
Registration Number
NCT00157807
Lead Sponsor
Medtronic Cardiac Surgery
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 coronary bypass surgery are the purposes of this study. 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 echocardiographic examinations of the heart to detect differences between the different treatment groups. The patients will be followed for one year after treatment.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
24
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 (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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Quality of life12 months
Cost of care12 months
Secondary Outcome Measures
NameTimeMethod
Atrial fibrillation12 months
Echo parameters12 months

Trial Locations

Locations (5)

Klinik für Herz-, Thorax- und Gefäßchirurgie

🇩🇪

Lahr, Baden Württemberg, Germany

Klinikum der Universität Muenchen Großhadern Cardiac Surgery

🇩🇪

München, Bayern, Germany

Klinik für Herz- und Thoraxchirurgie

🇩🇪

Bochum, Nordrhein-Westfalen, Germany

Klinik und Poliklinik für Herzchirurgie der Rhein. Friedrich-Wilhelms-Universität Bonn

🇩🇪

Bonn, Nordrhein-Westfalen, Germany

Klinik für Herz- und Thoraxchirurgie der Martin-Luther-Universität Halle-Wittenberg

🇩🇪

Halle, Sachsen, Germany

Klinik für Herz-, Thorax- und Gefäßchirurgie
🇩🇪Lahr, Baden Württemberg, Germany

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