Reappraisal of Atrial Fibrillation: RACE-V - Work Package 5
NCT ID: NCT03124576
Last Updated: 2018-07-19
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
380 participants
OBSERVATIONAL
2016-11-30
2021-10-31
Brief Summary
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For this purpose, in all included patients atrial biopsies will be taken during cardiac surgery.
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Detailed Description
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Four patient categories will be included enabling to study patients with different stages of AF progression;
1. Patients without history of atrial fibrillation, without new onset atrial fibrillation detected by continuous rhythm monitoring after surgery (control group),
2. Patients without history of atrial fibrillation, with new onset atrial fibrillation detected by continuous rhythm monitoring,
3. Patients with self-terminating atrial fibrillation at inclusion, and
4. Patients with non-self-terminating atrial fibrillation at inclusion. At baseline in-depth phenotyping and genotyping will be performed. Continuous rhythm monitoring will also be performed in all patients. The combination of extensive phenotyping, genotyping and atrial fibrillation burden follow-up offers the unique opportunity to study the atrial tissue alterations and atrial gene expression changes in different stages of atrial fibrillation progression and to correlate these data to the phenotype of the patients.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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control group
Without history of atrial fibrillation/without newly developed atrial fibrillation detected by continuous rhythm monitoring with a an Implantable loop recorder
Implantable loop recorder
Continuous rhythm monitoring Medtronic
group B
Patients without history of atrial fibrillation, with new onset atrial fibrillation detected by continuous rhythm monitoring with a an Implantable loop recorder
Implantable loop recorder
Continuous rhythm monitoring Medtronic
group C
Patients with self-terminating atrial fibrillation at inclusion Implantable loop recorder is used for continuous rhythm monitoring
Implantable loop recorder
Continuous rhythm monitoring Medtronic
group D
Patients with non-self-terminating atrial fibrillation at inclusion Implantable loop recorder is used for continuous rhythm monitoring
Implantable loop recorder
Continuous rhythm monitoring Medtronic
Interventions
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Implantable loop recorder
Continuous rhythm monitoring Medtronic
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Undergoing first elective open chest cardiac surgery or surgical ablation for atrial fibrillation;
* Able and willing to sign informed consent for the registry;
* Able and willing to undergo implantation of implantable loop recorder (unless the patients has a pacemaker or implantable cardioverter-defibrillator (ICD) with atrial leads)
Exclusion Criteria
* Pregnancy.
* Life expectancy of less than 2.5 years.
* History of prior cardiac surgery or ablation for atrial fibrillation.
18 Years
ALL
No
Sponsors
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Academisch Ziekenhuis Maastricht
OTHER
Responsible Party
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J. G. Maessen
Prof. Dr.
Principal Investigators
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Jos Maessen, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Academisch Ziekenhuis Maastricht
Locations
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AZMaastricht
Maastricht, Limburg, Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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Gilbers MD, Kawczynski MJ, Bidar E, Maesen B, Isaacs A, Winters J, Linz D, Rienstra M, van Gelder I, Maessen JG, Schotten U. Clinical Predictors of Device-Detected Atrial Fibrillation During 2.5 Years After Cardiac Surgery: Prospective RACE V Cohort. JACC Clin Electrophysiol. 2024 May;10(5):941-955. doi: 10.1016/j.jacep.2024.01.013. Epub 2024 Mar 13.
Other Identifiers
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NL56796.068.16
Identifier Type: -
Identifier Source: org_study_id
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