Reappraisal of Atrial Fibrillation: Interaction Between HyperCoagulability, Electrical Remodeling, and Vascular Destabilisation in the Progression of Atrial Fibrillation

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT02726698
• Lead Sponsor: University Medical Center Groningen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-17
• Study First Submitted QC: 2016-03-29
• Study First Posted: 2016-04-04
• Study Start: 2016-07
• Primary Completion: 2024-10
• Study Completion: 2024-10
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 750

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression of AF burden	2.5 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (9)

Laurentius Hospital; 🇳🇱 Roermond, Netherlands

Martini Hospital; 🇳🇱 Groningen, Netherlands

Isala; 🇳🇱 Zwolle, Netherlands

Amsterdam University Medical Center - VU; 🇳🇱 Amsterdam, Netherlands

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands

Rijnstate Hospital; 🇳🇱 Arnhem, Gelderland, Netherlands

Amsterdam University Medical Center - AMC; 🇳🇱 Amsterdam, Netherlands

Ommelander Ziekenhuis; 🇳🇱 Groningen, Netherlands