Clinical trial NCT02726698: Reappraisal of Atrial Fibrillation: Interaction Between HyperCoagulability, Electrical Remodeling, and Vascular Destabilisation in the Progression of Atrial Fibrillation
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Maastricht University Medical Center
First posted: 2016-04-04
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with paroxysmal (self-terminating) AF in the cardiology outpatient department, first (heart) aid and pacemaker clinic.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression of AF burden
timeFrame: 2.5 years
Secondary outcomes:
measure: Major Adverse Cardiac and Cerebrovascular Events
timeFrame: 2.5 years
measure: Change in therapy due to continuous rhythm monitoring with the LinQ/Carelink system
timeFrame: 2.5 years
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Gelderland
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Center - AMC
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Center - VU
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Groningen
country: Netherlands
facility: Martini Hospital
city: Groningen
country: Netherlands
facility: Ommelander Ziekenhuis
city: Roermond
country: Netherlands
facility: Laurentius Hospital
city: Zwolle
country: Netherlands
facility: Isala
Study officials:
affiliation: Maastricht University Medical Center
name: Harry JGM Crijns, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Groningen
name: Isabelle C van Gelder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.