READ-POAF Pilot Studies Postoperative Atrial Fibrillation After Cardiac Surgery
NCT ID: NCT01530750
Last Updated: 2012-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
40 participants
OBSERVATIONAL
2012-03-31
2014-02-28
Brief Summary
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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.
Detailed Description
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Postoperative atrial fibrillation (POAF) after cardiac surgery is a common (1 in 4) complication and associated with morbidity and mortality. Not all episodes of AF are noticed and detected, especially after discharge. several studies have shown high mortality in POAF patients, suggesting a progression in AF frequency.
Objective of the study:
To investigate the real incidence and burden of POAF. Afterwards a risk stratification of POAF is made. To identify a structural and electrophysiological substrate for the development of POAF and new onset AF during follow up.
Study design:
140 patients will receive a Reveal device. After 3 and 12 months data will be subtracted from the device. 100 of these patient will undergo additional mapping and tissue biopsies during operation.
Study population:
All patients undergoing cardiac surgery without a history of AF and without a pacemaker will be invited to participate in the study.
Primary study parameters/outcome of the study:
Incidence of POAF until 3 months after CABG.
Secondary study parameters/outcome of the study:
Incidence of POAF until 12 months after CABG. Determine risk factors for early and late POAF. Detect pre-operative (unnoticed) episodes of AF.
Determine a substrate for development of AF.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
There is a small risk of minor complications (hemorrhage and infection of the pocket).The device can be explanted easily if necessary. Ther is a burden of the im- and explantation of the device (local anesthesia, approx. 20 minutes). Patient will have to visit the out-hospital clinic twice.
The operation will be prolonged by 30 minutes due to mapping.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Post cardiac surgery
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Sinus rhythm on initial visit
Exclusion Criteria
* Internal pacemaker
60 Years
90 Years
ALL
No
Sponsors
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Maastricht University Medical Center
OTHER
Catharina Ziekenhuis Eindhoven
OTHER
Responsible Party
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Principal Investigators
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Bart van Straten, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
CZE
Sander Bramer, MD
Role: STUDY_DIRECTOR
CZE
Jos Maessen, MD. PhD
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Center
Locations
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Catharina Hospital
Eindhoven, , Netherlands
Maastricht University Medical Center
Maastricht, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Bramer
Role: primary
Bramer
Role: primary
References
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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.
Other Identifiers
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NL37204.060.11
Identifier Type: -
Identifier Source: org_study_id