Reappraisal of Atrial Fibrillation: RACE-V - Work Package 5 (RACE V- WP 5)

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

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.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Implantable loop recorder

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 380

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229 HX
      • Recruiting
      • AZMaastricht
      • Contact: Martijn Gilbers, Drs; Phone Number: 0031620606559; Email: martijn.gilbers@mumc.nl
      • Contact: Elham Bidar, Drs; Phone Number: 0031624266586; Email: elham.bidar@mumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

380 patiënts undergoing elective open chest heart surgery.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
control group; 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; Continuous rhythm monitoring Medtronic; Other Names: Reveal LINQ™,Medtronic; ConfirmTM, St. Jude; BiomonitorTM, Biotronik
group B; 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; Continuous rhythm monitoring Medtronic; Other Names: Reveal LINQ™,Medtronic; ConfirmTM, St. Jude; BiomonitorTM, Biotronik
group C; Patients with self-terminating atrial fibrillation at inclusion Implantable loop recorder is used for continuous rhythm monitoring	Device: Implantable loop recorder; Continuous rhythm monitoring Medtronic; Other Names: Reveal LINQ™,Medtronic; ConfirmTM, St. Jude; BiomonitorTM, Biotronik
group D; Patients with non-self-terminating atrial fibrillation at inclusion Implantable loop recorder is used for continuous rhythm monitoring	Device: Implantable loop recorder; Continuous rhythm monitoring Medtronic; Other Names: Reveal LINQ™,Medtronic; ConfirmTM, St. Jude; BiomonitorTM, Biotronik

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Academisch Ziekenhuis Maastricht
• Investigators: Principal Investigator: Jos Maessen, Prof. Dr., Academisch Ziekenhuis Maastricht

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: November 1, 2016
• First Submitted That Met QC Criteria: April 18, 2017
• First Posted (Actual): April 24, 2017

Study Record Updates

• Last Update Posted (Actual): July 19, 2018
• Last Update Submitted That Met QC Criteria: July 18, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: NL56796.068.16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED