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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02349269
Other study ID # samuelm1
Secondary ID
Status Completed
Phase N/A
First received December 1, 2014
Last updated January 23, 2015
Start date January 2012
Est. completion date September 2014

Study information

Verified date November 2014
Source Kuopio University Hospital
Contact n/a
Is FDA regulated No
Health authority Finland: Ministry of Social Affairs and Health
Study type Observational [Patient Registry]

Clinical Trial Summary

The aim of the investigators trial was to evaluate association between new onset postoperative atrial fibrillation (POAF) and late cardiovascular morbidity and mortality.


Description:

The material of this retrospective study consist patients without preoperative history of atrial fibrillation, participated in three different randomized controlled trials previously . A total of 519 consecutive patients underwent coronary artery bypass surgery, aortic valve replacement or combined aortic valve with coronary bypass surgery in Kuopio University Hospital from 2004 to 2008. Patients with previous episodes of atrial fibrillation (AF) or flutter and also patients with mitral valve surgery were excluded. All patients had continuous postoperative ECG monitoring for at least 48 hours. AF episodes lasting longer than 5 minutes were registered. Thereafter 12 lead ECG was recorded daily and in case of symptoms of rhythm disturbances.

Medical records were reviewed during 2012 using standardized data collection protocol. Statistics Finland database was used for mortality data.


Recruitment information / eligibility

Status Completed
Enrollment 519
Est. completion date September 2014
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- previously cardiac operation, CABG or AVR

Exclusion Criteria:

- Previous Atrial fibrillation

Study Design

N/A


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Kuopio University Hospital University of Eastern Finland

Outcome

Type Measure Description Time frame Safety issue
Primary cardiovascular and all-cause death 1-105 month No
Primary stroke 1-105 month No
Primary late atrial fibrillation 1-105 month No
Primary myocardial infarction 1-105 month No
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