Atrial Fibrillation in Cryptogenic Stroke and TIA

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

• Atrial Fibrillation
• Ischemic Stroke
• TIA

Interventions

DEVICE

Medtronic Reveal LINQ

Sponsors & Collaborators

• Ostfold Hospital Trust

  collaborator OTHER

• Haukeland University Hospital

  collaborator OTHER

• Rigshospitalet, Denmark

  collaborator OTHER

• Bispebjerg Hospital

  collaborator OTHER

• The Hospital of Vestfold

  collaborator OTHER

• Sykehuset Telemark

  collaborator OTHER_GOV

• Herlev Hospital

  collaborator OTHER

• Nordlandssykehuset HF

  collaborator OTHER

• Vestre Viken Hospital Trust

  collaborator OTHER

• Helse Stavanger HF

  collaborator OTHER_GOV

• Molde Hospital

  collaborator OTHER

• Drammen sykehus

  collaborator OTHER

• Diakonhjemmet Hospital

  collaborator OTHER

• University Hospital of North Norway

  collaborator OTHER

• Ullevaal University Hospital

  collaborator OTHER

• Sykehuset Innlandet HF

  collaborator OTHER

• Skane University Hospital

  collaborator OTHER

• Oslo University Hospital

  lead OTHER

Principal Investigators

• Anne Hege Aamodt, MD, PhD · Oslo University Hospital

• Dan Atar, MD, PhD · Oslo University Hospital

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-12-31

Primary Completion

2021-10-31

Completion

2021-10-31

Countries

• Norway

Study Locations