Cryptogenic Stroke Study

Transoma Medical

Status: Unknown

Conditions: Cryptogenic Stroke

Treatments: Device: Sleuth AT Implantable ECG Monitoring System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00861133

CLP-008

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)