Reappraisal of Atrial Fibrillation: Interaction between HyperCoagulability, Electrical Remodeling, and Vascular Destabilisation in the Progression of AF - An observational exploratory study on pathophysiological mechanisms of AF progression AND on the role of LinQ/ CareLink guided patient tailored therapy in patients with AF (RACE V)

Reappraisal of Atrial Fibrillation: Interaction between HyperCoagulability, Electrical Remodeling, and Vascular Destabilisation in the Progression of AF - An observational exploratory study on pathophysiological mechanisms of AF progression AND on the role of LinQ/ CareLink guided patient tailored therapy in patients with AF (RACE V) - RACE V

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50560

Enrollment

750

Registered

2016-03-15

Start date

2017-06-28

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atrial fibrillation. Alzheimers disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Age > 18 years; • Total history 190 bpm lasting > 6 minutes). • Able and willing to sign informed consent for the registry; • Able and willing to undergo implantation of ILR (in patients without a CIED); • CHA2DS2-VASc score

Exclusion criteria

Exclusion criteria: • Non-self-terminating, persistent AF; • Only AF due to a trigger (i.e. postoperative, due to infection); • Congenital heart disease; • Refusing to temporarily stop (N)OAC for coagulation phenotyping (in patients already on (N)OAC before inclusion in this study), with the exception for patients with a history of ischemic stroke/ transient ischemic attack; • Prior pulmonary vein isolation (PVI) or on waiting list for PVI or expected to be placed on waiting list within one year; • Expected to start with, or currently using amiodarone; • Pregnancy; • ICD, CRT or pacemaker that is not a Medtronic pacemaker; • Life expectancy of less than 2.5 years.; • Ventricular pacing >50% In patients with a Medtronic pacemaker.

Design outcomes

Primary

Measure	Time frame
Progression of AF, defined as self-terminating AF proceeding into non-self-terminating AF.	—

Secondary

Measure	Time frame
1. Feasibility of implementing changes in therapy in patients with selfterminating AF using the LinQ/ Carelink system 2. AF burden 3. Number of AF episodes 4. Duration of AF episodes 5. MACCE (i.e. death, stroke, myocardial infarction); 6. First recurrent AF; 7. Duration and frequency of AF episodes; 8. Self-terminating AF turning into non-self-terminating AF; 9. Electrical AF complexity measured from AF waves in 12 lead ECG in patients with recurrent AF; 10. Rhythm control strategy chosen by treating physician, including: • Rhythm control medication; • Electrical/pharmacological cardioversion; • Pulmonary vein isolation; 11. Echocardiographic parameters; 12. Cardiac CT parameters; 13. Prevalence and incidence of subclinical atherosclerosis and endothelial dysfunction; 14. Changes in blood biomarkers; 15. Prevalence of genotypes 16. Biomarkers in acute AF; 17. Biomarkers assessed locally in the atria; 18. Electrophysiological properties of the atria; 19. Quality of life;	—

Measure

Time frame

1. Feasibility of implementing changes in therapy in patients with selfterminating AF using the LinQ/ Carelink system 2. AF burden 3. Number of AF episodes 4. Duration of AF episodes 5. MACCE (i.e. death, stroke, myocardial infarction); 6. First recurrent AF; 7. Duration and frequency of AF episodes; 8. Self-terminating AF turning into non-self-terminating AF; 9. Electrical AF complexity measured from AF waves in 12 lead ECG in patients with recurrent AF; 10. Rhythm control strategy chosen by treating physician, including: • Rhythm control medication; • Electrical/pharmacological cardioversion; • Pulmonary vein isolation; 11. Echocardiographic parameters; 12. Cardiac CT parameters; 13. Prevalence and incidence of subclinical atherosclerosis and endothelial dysfunction; 14. Changes in blood biomarkers; 15. Prevalence of genotypes 16. Biomarkers in acute AF; 17. Biomarkers assessed locally in the atria; 18. Electrophysiological properties of the atria; 19. Quality of life;

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Countries

Netherlands

Outcome results