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

Study Overview
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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; Patients without history of atrial fibrillation, without new onset atrial fibrillation detected by continuous rhythm monitoring after surgery (control group), Patients without history of atrial fibrillation, with new onset atrial fibrillation detected by continuous rhythm monitoring, Patients with self-terminating atrial fibrillation at inclusion, and 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.

Official Title
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Reappraisal of Atrial Fibrillation: Interaction Between HyperCoagulability, Electrical Remodeling, and Vascular Destabilisation in the Progression of AF- The Tissue Bank Project

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Implantable loop recorder


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| control group<br>Without history of atrial fibrillation/without newly developed atrial fibrillation detected by continuous rhythm monitoring with a an Implantable loop recorder | Device: Implantable loop recorder<br>* Continuous rhythm monitoring Medtronic<br>* Other names: BiomonitorTM, Biotronik;|
| group B<br>Patients without history of atrial fibrillation, with new onset atrial fibrillation detected by continuous rhythm monitoring with a an Implantable loop recorder | Device: Implantable loop recorder<br>* Continuous rhythm monitoring Medtronic<br>* Other names: BiomonitorTM, Biotronik;|
| group C<br>Patients with self-terminating atrial fibrillation at inclusion Implantable loop recorder is used for continuous rhythm monitoring | Device: Implantable loop recorder<br>* Continuous rhythm monitoring Medtronic<br>* Other names: BiomonitorTM, Biotronik;|
| group D<br>Patients with non-self-terminating atrial fibrillation at inclusion Implantable loop recorder is used for continuous rhythm monitoring | Device: Implantable loop recorder<br>* Continuous rhythm monitoring Medtronic<br>* Other names: BiomonitorTM, Biotronik;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical factors in atrial biopsies and blood samples | Biochemical factors in atrial biopsies and blood samples associated with atrial fibrillation and contributing to atrial fibrillation progression | 2.5 year follow up | 
| Molecular factors in atrial biopsies and blood samples | Molecular factors in atrial biopsies and blood samples associated with atrial fibrillation and contributing to atrial fibrillation progression | 2.5 year follow up | 
| Genetic factors in atrial biopsies and blood samples | Genetic factors in atrial biopsies and blood samples associated with atrial fibrillation and contributing to atrial fibrillation progression | 2.5 year follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation burden | Atrial fibrillation burden | 2.5 year follow up | 
| Number of atrial fibrillation episodes | Number of atrial fibrillation episodes | 2.5 year follow up | 
| Duration of atrial fibrillation episodes | Duration of atrial fibrillation episodes | 2.5 year follow up | 
| Major adverse cardiovascular and cerebrovascular events | Major adverse cardiovascular and cerebrovascular events (i.e. death, stroke, myocardial infarction) | 2.5 year follow up | 
| First recurrent atrial fibrillation; | First recurrent atrial fibrillation | 2.5 year follow up | 
| AF progression | Self-terminating atrial fibrillation turning into non-self-terminating atrial fibrillation measured from ECGs and implantable loop recorders | 2.5 year follow up | 
| AF complexity | Electrical atrial fibrillation complexity or signs of atrial conduction disturbances measured from ECGs | 2.5 year follow up |