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Clinical Trials/NCT00861133
NCT00861133UnknownNot Applicable

Long-Term Cardiac Monitoring for Detection of Atrial Fibrillation After Cryptogenic Stroke

Transoma Medical2 sites in 1 country100 target enrollmentStarted: March 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
100
Locations
2
Primary Endpoint
Incidence of atrial fibrillation at one year from Sleuth implantation.

Study Overview

Brief Summary

The purpose of this study is to determine whether the Sleuth Implantable Loop Recorder will enhance detection of latent atrial fibrillation in patients after cryptogenic stroke.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Recent stroke (within 30 days) as defined by who has a sudden onset of focal neurological deficits presumed vascular etiology and lasting more than 24 hours.
  • Negative brain image for hemorrhagic stroke
  • In sinus rhythm at time of enrollment

Exclusion Criteria

  • Know history of atrial fibrillation
  • Previous implanted cardiac device (ppM or ICD)
  • Serious illness making it unlikely to survive one year
  • Known secondary cause of stroke

Outcomes

Primary Outcomes

Incidence of atrial fibrillation at one year from Sleuth implantation.

Time Frame: One Year

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry

Study Sites (2)

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