Reappraisal of Atrial Fibrillation: Interaction Between HyperCoagulability, Electrical Remodeling, and Vascular Destabilisation in the Progression of Atrial Fibrillation
NCT ID: NCT02726698
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
750 participants
OBSERVATIONAL
2016-07-31
2024-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Maastricht University Medical Center
OTHER
University Medical Center Groningen
OTHER
Responsible Party
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I.C. Van Gelder
Prof.dr.
Principal Investigators
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Harry JGM Crijns, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Center
Isabelle C van Gelder, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Groningen
Locations
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Rijnstate Hospital
Arnhem, Gelderland, Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands
Amsterdam University Medical Center - AMC
Amsterdam, , Netherlands
Amsterdam University Medical Center - VU
Amsterdam, , Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Martini Hospital
Groningen, , Netherlands
Ommelander Ziekenhuis
Groningen, , Netherlands
Laurentius Hospital
Roermond, , Netherlands
Isala
Zwolle, , Netherlands
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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NL53561.042.16
Identifier Type: -
Identifier Source: org_study_id