Clinical Trials Directory

Trials / Completed

CompletedNCT02937077

Atrial Fibrillation in Cryptogenic Stroke and TIA

The Nordic Atrial Fibrillation and Stroke Study

Status
Completed
Phase
Study type
Observational
Enrollment
259 (actual)
Sponsor
Oslo University Hospital · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

Background: Different studies with real-life data and randomized controlled trials have shown a detection rate of paroxysmal atrial fibrillation (AF) of 10-20% in patients with cryptogenic stroke using insertable continuous cardiac monitoring for 6 months. More studies are needed, however, to identify factors which can be used to select the patients where the possibility of detecting AF with prolonged rhythm monitoring is highest, to evaluate the best duration of rhythm monitoring, to determine the optimal definition of short-term AF that warrants intervention and to evaluate whether intervention results in improved clinical outcomes. Methods: The NOR-FIB study is a multi-centre prospective observational trial, designed to evaluate detection of AF in cryptogenic stroke and transient ischemic attack (TIA). Patients admitted with cryptogenic stroke or TIA in stroke units in the Nordic countries, aged 18-80 years are included and have the Reveal LINQ® Insertable cardiac monitor system implanted for 12 months for the purpose of AF detection. Biomarkers that may identify patients, who could derive the most clinical benefit from the detection of AF by prolonged monitoring, are being studied. Conclusion: This NOR-FIB study will increase our knowledge regarding the occurrence of AF in patients with cryptogenic stroke and TIA that potentially can improve secondary prevention. The study will provide information on biomarkers that may be used to select cryptogenic TIA and stroke patients for long-term monitoring as well as information on the significance of short-term AF and optimal duration of cardiac rhythm monitoring.

Conditions

Interventions

TypeNameDescription
DEVICEMedtronic Reveal LINQ

Timeline

Start date
2016-12-01
Primary completion
2021-10-01
Completion
2021-10-01
First posted
2016-10-18
Last updated
2022-01-25

Locations

2 sites across 1 country: Norway

Source: ClinicalTrials.gov record NCT02937077. Inclusion in this directory is not an endorsement.