Atrial Fibrillation
Conditions
Brief summary
The purpose of this study is to study clinical factors and (blood) biomarkers related to progression of Atrial Fibrillation (AF) in patients diagnosed with self-terminating AF with special reference to hypercoagulability. All patients will be continuously monitored for their atrial rhythm to assess AF progression, either through an implantable loop recorder (Reveal LinQ) or via the atrial lead of a cardiac implantable electronic device (CIED), both in combination with the CareLink home monitoring system. Remote monitoring and interrogation will be installed and used on a daily basis.
Interventions
None listed
Sponsors
Maastricht University Medical Center
University Medical Center Groningen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* New onset or history of paroxysmal, self-terminating AF documented as: * AF on ECG or Holter-recording or loop recorder * Subclinical AF detected in implantable cardiac devices (atrial read \> 190 beats per minute, lasting \> 6 minutes). * Prior history of self-terminating AF is allowed; * Able and willing to sign informed consent for the registry; * Able and willing to undergo implantation of an implantable loop recorder (in patients without a CIED); * In patients already on oral anticoagulation drugs, the following inclusion criteria need to be met (to allow for safe temporary interruption of anti-thrombotic treatment for coagulation phenotyping): * CHA2DS2-VASc score ≤5 (history of Congestive heart failure, Hypertension, Age ≥ 75 years (doubled), Diabetes mellitus,Stroke/transient ischemic attack (doubled), Vascular disease, Age 65-75 years, female Sex); * No other indication for oral anticoagulation (e.g. mechanical valve prosthesis); * Patient is willing to temporarily stop oral anticoagulation drugs (OAC).
Exclusion criteria
* Non-self-terminating, persistent AF; * Deemed unsuitable or not willing to undergo implantation of loop recorder (in patients without a CIED); * Refusing to temporarily stop OAC for coagulation phenotyping (in patients already on OAC before inclusion in this study); * On waiting list for pulmonary vein isolation or expected to be placed on waiting list within one year; * Expected to start with amiodarone; * Pregnancy; * Life expectancy of less than 2.5 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression of AF burden | 2.5 years |
Secondary
| Measure | Time frame |
|---|---|
| Major Adverse Cardiac and Cerebrovascular Events | 2.5 years |
| Change in therapy due to continuous rhythm monitoring with the LinQ/Carelink system | 2.5 years |
Countries
Netherlands
Outcome results
None listed