Reappraisal of Atrial Fibrillation: RACE-V - Work Package 5

NCT ID: NCT03124576

Last Updated: 2018-07-19

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

380 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2021-10-31

Brief Summary

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In the proposed study the investigators aim to clarify the relative contribution of these different mechanisms to the progression of atrial fibrillation (AF). Also the contribution of the individual genetic background will be investigated. Furthermore, the investigators aim to identify clinical parameters and biomarkers informing on the main mechanisms of AF progression in atrial tissue.

For this purpose, in all included patients atrial biopsies will be taken during cardiac surgery.

Detailed Description

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An estimated 380 patients will be included

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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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Intervention Type DEVICE

Continuous rhythm monitoring Medtronic

Interventions

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Implantable loop recorder

Continuous rhythm monitoring Medtronic

Intervention Type DEVICE

Other Intervention Names

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Reveal LINQ™,Medtronic ConfirmTM, St. Jude BiomonitorTM, Biotronik

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years;
* 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

* • Deemed unsuitable or not willing to undergo implantation of implantable loop recorder or attend follow-up visits.

* Pregnancy.
* Life expectancy of less than 2.5 years.
* History of prior cardiac surgery or ablation for atrial fibrillation.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Academisch Ziekenhuis Maastricht

OTHER

Sponsor Role lead

Responsible Party

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J. G. Maessen

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Martijn Gilbers, Drs.

Role: CONTACT

0031620606559

Facility Contacts

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Martijn Gilbers, Drs

Role: primary

0031620606559

Elham Bidar, Drs

Role: backup

0031624266586

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.

Reference Type DERIVED
PMID: 38483418 (View on PubMed)

Other Identifiers

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NL56796.068.16

Identifier Type: -

Identifier Source: org_study_id

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