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
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Coronary Artery Disease
Procedure: bipolar radiofrequency ablation of persistent and permanent AF

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Cost of care [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Atrial fibrillation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Echo parameters [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: September 2005
Study Completion Date: August 2013
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No Ablation
bipolar radiofrequency ablation of persistent and permanent AF
intra opertative bipolar RF ablation of persistent and permanent AF
Procedure: bipolar radiofrequency ablation of persistent and permanent AF

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00157807

Locations
Germany
Klinik für Herz-, Thorax- und Gefäßchirurgie
Lahr, Baden Württemberg, Germany, 77933
Klinikum der Universität Muenchen Großhadern Cardiac Surgery
München, Bayern, Germany, 81377
Klinik für Herz- und Thoraxchirurgie
Bochum, Nordrhein-Westfalen, Germany, 44789
Klinik und Poliklinik für Herzchirurgie der Rhein. Friedrich-Wilhelms-Universität Bonn
Bonn, Nordrhein-Westfalen, Germany, 53105
Klinik für Herz- und Thoraxchirurgie der Martin-Luther-Universität Halle-Wittenberg
Halle, Sachsen, Germany, 06120
Sponsors and Collaborators
Medtronic Bakken Research Center
Medtronic
Investigators
Principal Investigator: Calin Vicol, Professor Klinikum der Universität München Großhadern Cardiac Surgery
  More Information

Additional Information:
No publications provided

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00157807     History of Changes
Other Study ID Numbers: CEN_G_CS_1
Study First Received: September 8, 2005
Last Updated: August 22, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Medtronic Bakken Research Center:
Persistent Atrial Fibrillation
Permanent Atrial Fibrillation
Mitral Valve Defect
Tricuspid Valve Defect
Aortic Valve Defect

Additional relevant MeSH terms:
Atrial Fibrillation
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 23, 2014