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

NCT03124576 | Unknown DMC

• 1 other identifier: NL56796.068.16
• Study Type: observational
• Target: 380
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Atrial fibrillation burden

  2.5 year follow up

• Number of atrial fibrillation episodes

  2.5 year follow up

• Duration of atrial fibrillation episodes

  2.5 year follow up

• Major adverse cardiovascular and cerebrovascular events

  2.5 year follow up

• First recurrent atrial fibrillation;

  2.5 year follow up

Study Arms (4)

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

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

group C

Patients with self-terminating atrial fibrillation at inclusion Implantable loop recorder is used for continuous rhythm monitoring

Device: Implantable loop recorder

group D

Patients with non-self-terminating atrial fibrillation at inclusion Implantable loop recorder is used for continuous rhythm monitoring

Device: Implantable loop recorder

Interventions

Implantable loop recorder DEVICE

Continuous rhythm monitoring Medtronic

Also known as: Reveal LINQ™,Medtronic, ConfirmTM, St. Jude, BiomonitorTM, Biotronik

control group; group B; group C; group D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

380 patiënts undergoing elective open chest heart surgery.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academisch Ziekenhuis Maastricht: lead

Study Sites (1)

AZMaastricht

Maastricht, Limburg, 6229 HX, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 38483418 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

atrial tissue samples, whole blood

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jos Maessen, Prof. Dr.

  Academisch Ziekenhuis Maastricht

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martijn Gilbers, Drs.

CONTACT

0031620606559; M.Gilbers@maastrichtuniversity.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: April 24, 2017
• Study Start: November 1, 2016
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: July 19, 2018

Record last verified: 2018-07

Locations

NL (1)