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NCT02726698Completed

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

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

Source: ClinicalTrials.gov · Last updated 6 Dec 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
750 (estimated)
First submitted
17 Mar 2016
Start date
Jul 2016
Primary completion date
Oct 2024
Lead sponsor
University Medical Center Groningen
NCT number
NCT02726698

What you commit to

  • Study type: Observational
  • Planned participants: 750
  • From Jul 2016 to the primary completion date, Oct 2024
  • 9 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • 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.

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Amsterdam University Medical Center - AMC
Coordinator of this site? Confirm its status
AmsterdamNetherlandsUnknown status
Amsterdam University Medical Center - VU
Coordinator of this site? Confirm its status
AmsterdamNetherlandsUnknown status
Rijnstate Hospital
Coordinator of this site? Confirm its status
ArnhemNetherlandsUnknown status
University Medical Center Groningen
Coordinator of this site? Confirm its status
GroningenNetherlandsUnknown status
Ommelander Ziekenhuis
Coordinator of this site? Confirm its status
GroningenNetherlandsUnknown status
Martini Hospital
Coordinator of this site? Confirm its status
GroningenNetherlandsUnknown status
Maastricht University Medical Center
Coordinator of this site? Confirm its status
MaastrichtNetherlandsUnknown status
Laurentius Hospital
Coordinator of this site? Confirm its status
RoermondNetherlandsUnknown status
Isala
Coordinator of this site? Confirm its status
ZwolleNetherlandsUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.