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

This study has been terminated.
(no eligible patients can be found)
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00157807
First received: September 8, 2005
Last updated: February 14, 2017
Last verified: February 2017
September 8, 2005
February 14, 2017
September 2005
June 2008   (Final data collection date for primary outcome measure)
  • Quality of life [ Time Frame: 12 months ]
  • Cost of care [ Time Frame: 12 months ]
  • Quality of life
  • Cost of care
Complete list of historical versions of study NCT00157807 on ClinicalTrials.gov Archive Site
  • Atrial fibrillation [ Time Frame: 12 months ]
  • Echo parameters [ Time Frame: 12 months ]
  • Atrial fibrillation
  • Echo parameters
Not Provided
Not Provided
 
Clinical and Economic Consequences of Left Atrial Bipolar Radiofrequency Ablation of Persistent and Permanent Atrial Fibrillation During Cardiac Surgery
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
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Other
  • Atrial Fibrillation
  • Coronary Artery Disease
Procedure: bipolar radiofrequency ablation of persistent and permanent AF
  • No Intervention: No Ablation
  • bipolar radiofrequency ablation of persistent and permanent AF
    intra operative bipolar RF ablation of persistent and permanent AF
    Intervention: Procedure: bipolar radiofrequency ablation of persistent and permanent AF
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
24
August 2013
June 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00157807
CEN_G_CS_1
Not Provided
Not Provided
Not Provided
Medtronic Bakken Research Center
Medtronic Bakken Research Center
Medtronic
Principal Investigator: Calin Vicol, Professor Klinikum der Universität München Großhadern Cardiac Surgery
Medtronic Bakken Research Center
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP