NCT00783900

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
316

participants targeted

Target at P50-P75 for phase_4 atrial-fibrillation

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 3, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

March 3, 2017

Status Verified

November 1, 2011

Enrollment Period

2.9 years

First QC Date

October 31, 2008

Last Update Submit

March 1, 2017

Conditions

Atrial FibrillationBiatrial PacingMetoprolol

Keywords

Prevention

Outcome Measures

Primary Outcomes (2)

  • biatriac pacing

    48 hours

  • Incidence of atrial fibrillation

    48 hours

Study Arms (2)

metoprolol

ACTIVE COMPARATOR
Other: metoprolol, biatrial pacing

biatrial pacing

ACTIVE COMPARATOR
Other: metoprolol, biatrial pacing

Interventions

metoprolol, biatrial pacingOTHER

Prevention, atrial fibrillation, cardiac surgery, biatrial pacing, metoprolol

biatrial pacingmetoprolol

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • elective CABG and aortic valve cardiac patients,
  • previous use of beta blocker

You may not qualify if:

  • Previous episodes of Atrial fibrillation or flutter,
  • II or II degree atrioventricular block, uncontrolled heart failure
  • Sick sinus syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Halonen Jari

Kuopio, FIN-70211, Finland

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Metoprolol

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 31, 2008

First Posted

November 3, 2008

Study Start

January 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

March 3, 2017

Record last verified: 2011-11

Locations

FI(1)