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Completed

NCT Number: NCT02726698

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rijnstate Hospital, Arnhem, Gelderland, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Progression of AF burden

    Time frame: 2.5 years

Secondary outcomes

  1. Major Adverse Cardiac and Cerebrovascular Events

    Time frame: 2.5 years

  2. Change in therapy due to continuous rhythm monitoring with the LinQ/Carelink system

    Time frame: 2.5 years

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • Maastricht University Medical Center

Registry information

Official study title

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

Acronym: RACE V

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Apr 4, 2016
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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