Reappraisal of Atrial Fibrillation: Interaction Between HyperCoagulability, Electrical Remodeling, and Vascular Destabilisation in the Progression of Atrial Fibrillation - An Observational Exploratory Study on Pathophysiological Mechanisms of AF Progression and on the Role of LinQ/CareLink Guided Patient Tailored Therapy in Patients With Atrial Fibrillation

University Medical Center Groningen9 sites in 1 country750 target enrollmentJuly 2016

ConditionsAtrial Fibrillation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Atrial Fibrillation
Sponsor: University Medical Center Groningen
Enrollment: 750
Locations: 9
Primary Endpoint: Progression of AF burden
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2016

End Date

October 2024

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

University Medical Center Groningen

Responsible Party

Principal Investigator

I.C. Van Gelder

Prof.dr.

University Medical Center Groningen

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Progression of AF burden

Time Frame: 2.5 years

Secondary Outcomes

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)