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

Atrial Fibrillation Clinical Trial

— RACE V- WP 5  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03124576
• Other study ID #: NL56796.068.16
• Status: Recruiting
• Start date: November 2016
• Est. completion date: October 2021

Study information

• Verified date: July 2018
• Source: Academisch Ziekenhuis Maastricht
• Contact: Martijn Gilbers, Drs.
• Phone: 0031620606559
• Email: M.Gilbers[@]maastrichtuniversity.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 380
• Est. completion date: October 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Implantable loop recorder
Continuous rhythm monitoring Medtronic

Locations

Country	Name	City	State
Netherlands	AZMaastricht	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Ziekenhuis Maastricht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Atrial fibrillation burden	Atrial fibrillation burden	2.5 year follow up
Secondary	Number of atrial fibrillation episodes	Number of atrial fibrillation episodes	2.5 year follow up
Secondary	Duration of atrial fibrillation episodes	Duration of atrial fibrillation episodes	2.5 year follow up
Secondary	Major adverse cardiovascular and cerebrovascular events	Major adverse cardiovascular and cerebrovascular events (i.e. death, stroke, myocardial infarction)	2.5 year follow up
Secondary	First recurrent atrial fibrillation;	First recurrent atrial fibrillation	2.5 year follow up
Secondary	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
Secondary	AF complexity	Electrical atrial fibrillation complexity or signs of atrial conduction disturbances measured from ECGs	2.5 year follow up