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)

Completed

• Conditions: atrial fibrillation. Alzheimers disease; 10007521; 10012272

• Registration Number: NL-OMON50560
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 750

Inclusion Criteria

• Age > 18 years;
• Total history <10 years of paroxysmal, self-terminating AF;
• At least one documented episode of AF and 2 symptomatic episodes or two
documented episodes, documented as:
o AF on ECG, Holter-recording, loop recorder, event recorder or MyDiagnostic;
or
o Subclinical AF (SCAF) detected in a Medtronic pacemaker (atrial read > 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 <=5
• No other indication for oral anticoagulation (e.g. mechanical valve
prosthesis)

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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Progression of AF, defined as self-terminating AF proceeding into<br /><br>non-self-terminating AF.</p><br>