NCT01530750

Brief Summary

Postoperative atrial fibrillation after coronary artery bypass grafting will be monitored up to 1 year after the procedure by implanting a Reveal XT internal loop recorder two weeks before the surgery. Frequency, burden, and possible risk factors will be described. During the operation direct contact epicardial mapping will be performed and tissue samples will be collected to identify an electrophysiological and a structural substrate for development of AF.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

February 8, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2012

Completed
20 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

September 3, 2012

Status Verified

August 1, 2012

Enrollment Period

11 months

First QC Date

February 8, 2012

Last Update Submit

August 31, 2012

Conditions

Atrial Fibrillation

Keywords

postoperative atrial fibrillationinternal loop recorderrisk factorscoronary artery bypass surgery

Outcome Measures

Primary Outcomes (1)

  • atrial fibrillation (AF)

    frequency, frequency distribution, and burden of AF

    3 months

Secondary Outcomes (1)

  • atrial fibrillation (AF)

    12 months

Study Arms (1)

Post cardiac surgery

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

those patients undergoing cardiac surgery.

You may qualify if:

  • Undergoing non emergency surgery
  • Sinus rhythm on initial visit

You may not qualify if:

  • History of atrial fibrillation
  • Internal pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Catharina Hospital

Eindhoven, Netherlands

RECRUITING

Maastricht University Medical Center

Maastricht, Netherlands

NOT YET RECRUITING

Related Publications (1)

  • Bidar E, Zeemering S, Gilbers M, Isaacs A, Verheule S, Zink MD, Maesen B, Bramer S, Kawczynski M, Van Gelder IC, Crijns HJGM, Maessen JG, Schotten U. Clinical and electrophysiological predictors of device-detected new-onset atrial fibrillation during 3 years after cardiac surgery. Europace. 2021 Dec 7;23(12):1922-1930. doi: 10.1093/europace/euab136.

    PMID: 34198338DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bart van Straten, MD, PhD

    CZE

    PRINCIPAL INVESTIGATOR

  • Sander Bramer, MD

    CZE

    STUDY DIRECTOR

  • Jos Maessen, MD. PhD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sander Bramer, MD

CONTACT

+31402398680sander.bramer@cze.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2012

First Posted

February 10, 2012

Study Start

March 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2014

Last Updated

September 3, 2012

Record last verified: 2012-08

Locations

NL(2)