This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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
  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
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Other
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 ]
  • Cost of care [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Atrial fibrillation [ Time Frame: 12 months ]
  • Echo parameters [ Time Frame: 12 months ]

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 operative 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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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: February 14, 2017

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 June 27, 2017