Cryptogenic Stroke Study

May 4, 2009 updated by: Transoma Medical

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

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 Overview

Status

Unknown

Conditions

Cryptogenic Stroke

Intervention / Treatment

Device: Sleuth AT Implantable ECG Monitoring System

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Ohio
  - Columbus, Ohio, United States, 43210
    - Recruiting
    - The Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of atrial fibrillation at one year from Sleuth implantation. Time Frame: One Year	One Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Transoma Medical

Investigators

Principal Investigator: Andrew Krahn, MD, Western University, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Anticipated)

April 1, 2011

Study Completion (Anticipated)

May 1, 2011

Study Registration Dates

First Submitted

March 12, 2009

First Submitted That Met QC Criteria