NCT00861133UnknownNot Applicable
Long-Term Cardiac Monitoring for Detection of Atrial Fibrillation After Cryptogenic Stroke
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Transoma Medical
- 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
Study Sites (2)
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