Cryptogenic Stroke Study

Cryptogenic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00861133
• Other study ID #: CLP-008
• Status: Recruiting
• Phase: N/A
• First received: March 12, 2009
• Last updated: May 4, 2009
• Start date: March 2009
• Est. completion date: May 2011

Study information

• Verified date: May 2009
• Source: Transoma Medical
• Contact: M Broich
• Email: mbroich[@]transomamedical.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cryptogenic Stroke
• Stroke

Intervention

Device:
• Sleuth AT Implantable ECG Monitoring System
The study device provides monitoring only. It cannot provide intervention or treatment.

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Transoma Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of atrial fibrillation at one year from Sleuth implantation.		One Year	No