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

Coronary Artery Disease Clinical Trial

Official title:

Clinical and Economic Consequences of Left Atrial Bipolar Radiofrequency Ablation of Persistent and Permanent Atrial Fibrillation During Cardiac Surgery. A Prospective Randomized Multi Center Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00157807
• Other study ID #: CEN_G_CS_1
• Status: Terminated
• Phase: N/A
• First received: September 8, 2005
• Last updated: February 14, 2017
• Start date: September 2005
• Est. completion date: August 2013

Study information

• Verified date: February 2017
• Source: Medtronic Bakken Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: August 2013
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• bipolar radiofrequency ablation of persistent and permanent AF

Locations

Country	Name	City	State
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	Klinikum der Universität Muenchen Großhadern Cardiac Surgery	München	Bayern

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center	Medtronic

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life		12 months
Primary	Cost of care		12 months
Secondary	Atrial fibrillation		12 months
Secondary	Echo parameters		12 months

External Links

•   Herzchirurgie
•   Klinikum der Universität