Reappraisal of Atrial Fibrillation: Interaction Between HyperCoagulability, Electrical Remodeling, and Vascular Destabilisation in the Progression of AF- The Tissue Bank Project
| Registry | NCT03124576, acronym RACE V- WP 5 |
|---|---|
| Status | Unknown |
| Study type | Observational |
| Enrollment | 380 (Estimated) |
| Sponsor | Academisch Ziekenhuis Maastricht (Other) |
| Conditions | Atrial Fibrillation |
| Interventions | Implantable loop recorder (Device) |
| Dates | start 2016-11-01, primary completion 2021-10-01 (estimated), completion 2021-10-01 (estimated), first posted 2017-04-24, last updated 2018-07-19 |
| Locations | 1 site in Netherlands |
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Atrial Fibrillation All trials of Implantable loop recorder
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| control group | Device: Implantable loop recorder | Without history of atrial fibrillation/without newly developed atrial fibrillation detected by continuous rhythm monitoring with a an Implantable loop recorder | |
| group B | Device: Implantable loop recorder | Patients without history of atrial fibrillation, with new onset atrial fibrillation detected by continuous rhythm monitoring with a an Implantable loop recorder | |
| group C | Device: Implantable loop recorder | Patients with self-terminating atrial fibrillation at inclusion Implantable loop recorder is used for continuous rhythm monitoring | |
| group D | Device: Implantable loop recorder | Patients with non-self-terminating atrial fibrillation at inclusion Implantable loop recorder is used for continuous rhythm monitoring |
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| AZMaastricht | Maastricht, Limburg | Netherlands | Recruiting |