NCT02726698

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 4, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

December 6, 2024

Status Verified

December 1, 2024

Enrollment Period

8.3 years

First QC Date

March 17, 2016

Last Update Submit

December 5, 2024

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Progression of AF burden

    2.5 years

Secondary Outcomes (2)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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);
  • 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).

You may not qualify if:

  • Non-self-terminating, persistent AF;
  • Deemed unsuitable or not willing to undergo implantation of loop recorder (in patients without a CIED);
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Rijnstate Hospital

Arnhem, Gelderland, 6815 AD, Netherlands

Location

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

Location

Amsterdam University Medical Center - AMC

Amsterdam, Netherlands

Location

Amsterdam University Medical Center - VU

Amsterdam, Netherlands

Location

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

Martini Hospital

Groningen, 9728 NT, Netherlands

Location

Ommelander Ziekenhuis

Groningen, Netherlands

Location

Laurentius Hospital

Roermond, Netherlands

Location

Isala

Zwolle, Netherlands

Location

Related Publications (10)

  • Frausing MHJP, Rienstra M, Kronborg MB, De Melis M, Schotten U, Nielsen JC, Tieleman R, Crijns HJ, Van Gelder IC, Samuel M. Association between circulating biomarkers and atrial fibrillation burden in patients with paroxysmal atrial fibrillation: a subanalysis of the RACE V study. Open Heart. 2025 Sep 30;12(2):e003433. doi: 10.1136/openhrt-2025-003433.

    PMID: 41033708DERIVED

  • van Deutekom C, van de Lande ME, Rama R, Nguyen BO, Tieleman RG, Weberndorfer V, Hemels MEW, de Melis M, Schotten U, Linz D, Crijns HJGM, van Gelder IC, Rienstra M; RACE V Investigators. Multimorbidity Is Associated With Symptom Severity and Disease Progression in Patients with Paroxysmal Atrial Fibrillation-Data From the RACE V Study. J Am Heart Assoc. 2025 Mar 4;14(5):e034514. doi: 10.1161/JAHA.123.034514. Epub 2025 Feb 26.

    PMID: 40008502DERIVED

  • Koldenhof T, Van Gelder IC, van de Lande ME, Al-Jazairi MIH, Tieleman RG, Rienstra M. High heart rates during paroxysmal atrial fibrillation: continuous rhythm monitoring data of the RACE V study. Heart. 2024 Oct 10;110(21):1250-1253. doi: 10.1136/heartjnl-2024-324376.

    PMID: 39168591DERIVED

  • Frausing MHJP, Van De Lande M, Linz D, Crijns HJGM, Tieleman RG, Hemels MEW, De Melis M, Schotten U, Kronborg MB, Nielsen JC, Van Gelder I, Rienstra M. Healthcare utilisation and quality of life according to atrial fibrillation burden, episode frequency and duration. Heart. 2024 Jul 25;110(16):1030-1039. doi: 10.1136/heartjnl-2024-324016.

    PMID: 38944418DERIVED

  • van de Lande ME, Rama RS, Koldenhof T, Arita VA, Nguyen BO, van Deutekom C, Weberndorfer V, Crijns HJGM, Hemels MEW, Tieleman RG, de Melis M, Schotten U, Linz D, Van Gelder IC, Rienstra M; RACE V Investigators. Time of onset of atrial fibrillation and atrial fibrillation progression data from the RACE V study. Europace. 2023 May 19;25(5):euad058. doi: 10.1093/europace/euad058.

    PMID: 36967470DERIVED

  • Frausing MHJP, Van De Lande ME, Maass AH, Nguyen BO, Hemels MEW, Tieleman RG, Koldenhof T, De Melis M, Linz D, Schotten U, Weberndorfer V, Crijns HJGM, Van Gelder IC, Nielsen JC, Rienstra M. Brady- and tachyarrhythmias detected by continuous rhythm monitoring in paroxysmal atrial fibrillation. Heart. 2023 Aug 11;109(17):1286-1293. doi: 10.1136/heartjnl-2022-322253.

    PMID: 36948572DERIVED

  • Artola Arita V, Van De Lande ME, Khalilian Ekrami N, Nguyen BO, Van Melle JM, Geelhoed B, De With RR, Weberndorfer V, Erkuner O, Hillege H, Linz D, Ten Cate H, Spronk HMH, Koldenhof T, Tieleman RG, Schotten U, Crijns HJGM, Van Gelder IC, Rienstra M. Clinical utility of the 4S-AF scheme in predicting progression of atrial fibrillation: data from the RACE V study. Europace. 2023 Apr 15;25(4):1323-1331. doi: 10.1093/europace/euac268.

    PMID: 36857318DERIVED

  • Nguyen BO, Weberndorfer V, Crijns HJ, Geelhoed B, Ten Cate H, Spronk H, Kroon A, De With R, Al-Jazairi M, Maass AH, Blaauw Y, Tieleman RG, Hemels MEW, Luermans J, de Groot J, Allaart CP, Elvan A, De Melis M, Scheerder C, van Zonneveld AJ, Schotten U, Linz D, Van Gelder I, Rienstra M. Prevalence and determinants of atrial fibrillation progression in paroxysmal atrial fibrillation. Heart. 2022 Jul 20;109(3):186-94. doi: 10.1136/heartjnl-2022-321027. Online ahead of print.

    PMID: 35858774DERIVED

  • De With RR, Artola Arita V, Nguyen BO, Linz D, Ten Cate H, Spronk H, Schotten U, Jan van Zonneveld A, Erkuner O, Bayon MA, Schmidt AS, Luermans JGLM, Crijns HJGM, Van Gelder IC, Rienstra M. Different circulating biomarkers in women and men with paroxysmal atrial fibrillation: results from the AF-RISK and RACE V studies. Europace. 2022 Feb 2;24(2):193-201. doi: 10.1093/europace/euab179.

    PMID: 34329401DERIVED

  • De With RR, Erkuner O, Rienstra M, Nguyen BO, Korver FWJ, Linz D, Cate Ten H, Spronk H, Kroon AA, Maass AH, Blaauw Y, Tieleman RG, Hemels MEW, de Groot JR, Elvan A, de Melis M, Scheerder COS, Al-Jazairi MIH, Schotten U, Luermans JGLM, Crijns HJGM, Van Gelder IC; RACE V Investigators. Temporal patterns and short-term progression of paroxysmal atrial fibrillation: data from RACE V. Europace. 2020 Aug 1;22(8):1162-1172. doi: 10.1093/europace/euaa123.

    PMID: 32642768DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Harry JGM Crijns, MD, PhD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

  • Isabelle C van Gelder, MD, PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.dr.

Study Record Dates

First Submitted

March 17, 2016

First Posted

April 4, 2016

Study Start

July 1, 2016

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

December 6, 2024

Record last verified: 2024-12

Locations

NL(9)