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

Academisch Ziekenhuis Maastricht

Status: Unknown

Conditions: Atrial Fibrillation

Treatments: Device: Implantable loop recorder

Study type: Observational

Funder types: Other

Identifiers

NCT03124576

NL56796.068.16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 380 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

380 participants in 4 patient groups

control group

Description:

Without history of atrial fibrillation/without newly developed atrial fibrillation detected by continuous rhythm monitoring with a an Implantable loop recorder

Treatment:

Device: Implantable loop recorder

group B

Description:

Patients without history of atrial fibrillation, with new onset atrial fibrillation detected by continuous rhythm monitoring with a an Implantable loop recorder

Treatment:

Device: Implantable loop recorder

group C

Description:

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

Treatment:

Device: Implantable loop recorder

group D

Description:

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

Treatment:

Device: Implantable loop recorder