Intravenous Administration of Metoprolol Versus Biatrial Pacing in the Prevention of Atrial Fibrillation After Cardiac Surgery
Primary Purpose
Atrial Fibrillation, Biatrial Pacing, Metoprolol
Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
metoprolol, biatrial pacing
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring Prevention
Eligibility Criteria
Inclusion Criteria:
- elective CABG and aortic valve cardiac patients,
- previous use of beta blocker
Exclusion Criteria:
- Previous episodes of Atrial fibrillation or flutter,
- II or II degree atrioventricular block, uncontrolled heart failure
- Sick sinus syndrome
Sites / Locations
- Halonen Jari
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
metoprolol
biatrial pacing
Arm Description
Outcomes
Primary Outcome Measures
biatriac pacing
Incidence of atrial fibrillation
Secondary Outcome Measures
Full Information
NCT ID
NCT00783900
First Posted
October 31, 2008
Last Updated
March 1, 2017
Sponsor
Kuopio University Hospital
Collaborators
Oulu University Hospital, Hospital Cordia, Kuopio, Finland
1. Study Identification
Unique Protocol Identification Number
NCT00783900
Brief Title
Intravenous Administration of Metoprolol Versus Biatrial Pacing in the Prevention of Atrial Fibrillation After Cardiac Surgery
Official Title
Intravenous Metoprolol Versus Biatrial Pacing in the Prevention of Atrial Fibrillation After Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Kuopio University Hospital
Collaborators
Oulu University Hospital, Hospital Cordia, Kuopio, Finland
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to compare the effectiviness of biatrial pacing versus intravenous administration of metoprolol in the prevention of atrial fibrillation after cardiac surgery
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Biatrial Pacing, Metoprolol
Keywords
Prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
316 (Actual)
8. Arms, Groups, and Interventions
Arm Title
metoprolol
Arm Type
Active Comparator
Arm Title
biatrial pacing
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
metoprolol, biatrial pacing
Intervention Description
Prevention, atrial fibrillation, cardiac surgery, biatrial pacing, metoprolol
Primary Outcome Measure Information:
Title
biatriac pacing
Time Frame
48 hours
Title
Incidence of atrial fibrillation
Time Frame
48 hours
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
elective CABG and aortic valve cardiac patients,
previous use of beta blocker
Exclusion Criteria:
Previous episodes of Atrial fibrillation or flutter,
II or II degree atrioventricular block, uncontrolled heart failure
Sick sinus syndrome
Facility Information:
Facility Name
Halonen Jari
City
Kuopio
ZIP/Postal Code
FIN-70211
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Intravenous Administration of Metoprolol Versus Biatrial Pacing in the Prevention of Atrial Fibrillation After Cardiac Surgery
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