Back to resultsCryptogenic Stroke Study
Primary Purpose
Cryptogenic Stroke
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleuth AT Implantable ECG Monitoring System
Sponsored by
About this trial
This is an interventional diagnostic trial for Cryptogenic Stroke focused on measuring cardiac monitor, loop recorder, stroke, ECG, Implantable Loop Recorder, cryptogenic, ILR
Eligibility Criteria
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
Sites / Locations
- The Ohio State UniversityRecruiting
Outcomes
Primary Outcome Measures
Incidence of atrial fibrillation at one year from Sleuth implantation.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00861133
Brief Title
Cryptogenic Stroke Study
Official Title
Long-Term Cardiac Monitoring for Detection of Atrial Fibrillation After Cryptogenic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
May 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Transoma Medical
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cryptogenic Stroke
Keywords
cardiac monitor, loop recorder, stroke, ECG, Implantable Loop Recorder, cryptogenic, ILR
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Sleuth AT Implantable ECG Monitoring System
Intervention Description
The study device provides monitoring only. It cannot provide intervention or treatment.
Primary Outcome Measure Information:
Title
Incidence of atrial fibrillation at one year from Sleuth implantation.
Time Frame
One Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
M Broich
Email
mbroich@transomamedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Krahn, MD
Organizational Affiliation
Western University, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Cryptogenic Stroke Study
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