Back to resultsClinical and Economic Consequences of Left Atrial Bipolar Radiofrequency Ablation of Persistent and Permanent Atrial Fibrillation During Cardiac Surgery
Primary Purpose
Atrial Fibrillation, Coronary Artery Disease
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
bipolar radiofrequency ablation of persistent and permanent AF
Sponsored by
About this trial
This is an interventional other trial for Atrial Fibrillation focused on measuring Persistent Atrial Fibrillation, Permanent Atrial Fibrillation, Mitral Valve Defect, Tricuspid Valve Defect, Aortic Valve Defect
Eligibility 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
Sites / Locations
- Klinik für Herz-, Thorax- und Gefäßchirurgie
- Klinikum der Universität Muenchen Großhadern Cardiac Surgery
- Klinik für Herz- und Thoraxchirurgie
- Klinik und Poliklinik für Herzchirurgie der Rhein. Friedrich-Wilhelms-Universität Bonn
- Klinik für Herz- und Thoraxchirurgie der Martin-Luther-Universität Halle-Wittenberg
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
No Ablation
bipolar radiofrequency ablation of persistent and permanent AF
Arm Description
intra operative bipolar RF ablation of persistent and permanent AF
Outcomes
Primary Outcome Measures
Quality of life
Cost of care
Secondary Outcome Measures
Atrial fibrillation
Echo parameters
Full Information
NCT ID
NCT00157807
First Posted
September 8, 2005
Last Updated
February 14, 2017
Sponsor
Medtronic Bakken Research Center
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT00157807
Brief Title
Clinical and Economic Consequences of Left Atrial Bipolar Radiofrequency Ablation of Persistent and Permanent Atrial Fibrillation During Cardiac Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
no eligible patients can be found
Study Start Date
September 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Bakken Research Center
Collaborators
Medtronic
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Coronary Artery Disease
Keywords
Persistent Atrial Fibrillation, Permanent Atrial Fibrillation, Mitral Valve Defect, Tricuspid Valve Defect, Aortic Valve Defect
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No Ablation
Arm Type
No Intervention
Arm Title
bipolar radiofrequency ablation of persistent and permanent AF
Arm Type
Other
Arm Description
intra operative bipolar RF ablation of persistent and permanent AF
Intervention Type
Procedure
Intervention Name(s)
bipolar radiofrequency ablation of persistent and permanent AF
Primary Outcome Measure Information:
Title
Quality of life
Time Frame
12 months
Title
Cost of care
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Atrial fibrillation
Time Frame
12 months
Title
Echo parameters
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Calin Vicol, Professor
Organizational Affiliation
Klinikum der Universität München Großhadern Cardiac Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik für Herz-, Thorax- und Gefäßchirurgie
City
Lahr
State/Province
Baden Württemberg
ZIP/Postal Code
77933
Country
Germany
Facility Name
Klinikum der Universität Muenchen Großhadern Cardiac Surgery
City
München
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
Facility Name
Klinik für Herz- und Thoraxchirurgie
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44789
Country
Germany
Facility Name
Klinik und Poliklinik für Herzchirurgie der Rhein. Friedrich-Wilhelms-Universität Bonn
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53105
Country
Germany
Facility Name
Klinik für Herz- und Thoraxchirurgie der Martin-Luther-Universität Halle-Wittenberg
City
Halle
State/Province
Sachsen
ZIP/Postal Code
06120
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://www.klinikum.uni-muenchen.de
Description
Klinikum der Universität
URL
http://hch.klinikum.uni-muenchen.de
Description
Herzchirurgie
Learn more about this trial
Clinical and Economic Consequences of Left Atrial Bipolar Radiofrequency Ablation of Persistent and Permanent Atrial Fibrillation During Cardiac Surgery
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