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: August 22, 2013
Last verified: May 2013

September 8, 2005
August 22, 2013
September 2005
June 2008   (final data collection date for primary outcome measure)
  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Cost of care [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Echo parameters [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • 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 opertative 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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00157807
CEN_G_CS_1
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
May 2013

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