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
• Interventions: Procedure: bipolar radiofrequency ablation of persistent and permanent AF

• 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

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-10
• Study First Posted: 2005-09-12
• Primary Completion: 2008-06
• Study Completion: 2013-08
• Status Verified: 2017-02
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08

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

Arm && Interventions

Group	Intervention	Description
bipolar radiofrequency ablation of persistent and permanent AF	bipolar radiofrequency ablation of persistent and permanent AF	intra operative bipolar RF ablation of persistent and permanent AF

Primary Outcome Measures

Name	Time	Method
Quality of life	12 months
Cost of care	12 months

Secondary Outcome Measures

Name	Time	Method
Echo parameters	12 months
Atrial fibrillation	12 months

Trial Locations

Locations (5)

Klinikum der Universität Muenchen Großhadern Cardiac Surgery; 🇩🇪 München, Bayern, Germany

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