Status:
COMPLETED
Reappraisal of Atrial Fibrillation: Interaction Between HyperCoagulability, Electrical Remodeling, and Vascular Destabilisation in the Progression of Atrial Fibrillation
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
Maastricht University Medical Center
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT02726698
Start Date
July 1 2016
End Date
October 1 2024
Last Update
December 6 2024
Active Locations (9)
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1
Rijnstate Hospital
Arnhem, Gelderland, Netherlands, 6815 AD
2
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6229 HX
3
Amsterdam University Medical Center - AMC
Amsterdam, Netherlands
4
Amsterdam University Medical Center - VU
Amsterdam, Netherlands