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Cryptogenic Stroke Study

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00861133
Enrollment
100
Registered
2009-03-13
Start date
2009-03-31
Completion date
2011-05-31
Last updated
2009-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cryptogenic Stroke

Keywords

cardiac monitor, loop recorder, stroke, ECG, Implantable Loop Recorder, cryptogenic, ILR

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.

Interventions

DEVICESleuth AT Implantable ECG Monitoring System

The study device provides monitoring only. It cannot provide intervention or treatment.

Sponsors

Transoma Medical
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Incidence of atrial fibrillation at one year from Sleuth implantation.One Year

Countries

United States

Contacts

Primary ContactM Broich
mbroich@transomamedical.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026