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

May 9, 2023 updated by: I.C. Van Gelder, University Medical Center Groningen

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • Amsterdam University Medical Center - AMC
      • Amsterdam, Netherlands
        • Amsterdam University Medical Center - VU
      • Groningen, Netherlands, 9713 GZ
        • University Medical Center Groningen
      • Groningen, Netherlands, 9728 NT
        • Martini Hospital
      • Groningen, Netherlands
        • Ommelander Ziekenhuis
      • Roermond, Netherlands
        • Laurentius Hospital
      • Zwolle, Netherlands
        • Isala
    • Gelderland
      • Arnhem, Gelderland, Netherlands, 6815 AD
        • Rijnstate Hospital
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 HX
        • Maastricht University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with paroxysmal (self-terminating) AF in the cardiology outpatient department, first (heart) aid and pacemaker clinic.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression of AF burden
Time Frame: 2.5 years
2.5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Major Adverse Cardiac and Cerebrovascular Events
Time Frame: 2.5 years
2.5 years
Change in therapy due to continuous rhythm monitoring with the LinQ/Carelink system
Time Frame: 2.5 years
2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Collaborators

Maastricht University Medical Center

Investigators

  • Principal Investigator: Harry JGM Crijns, MD, PhD, Maastricht University Medical Center
  • Principal Investigator: Isabelle C van Gelder, MD, PhD, University Medical Center Groningen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Anticipated)

October 1, 2024

Study Completion (Anticipated)

October 1, 2024

Study Registration Dates

First Submitted

March 17, 2016

First Submitted That Met QC Criteria

March 29, 2016

First Posted (Estimate)

April 4, 2016

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL53561.042.16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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