Cryptogenic Stroke Study

NCT ID: NCT00861133

Last Updated: 2009-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cryptogenic Stroke

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Sleuth AT Implantable ECG Monitoring System

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Transoma Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Tranoma Medical

Principal Investigators

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Andrew Krahn, MD

Role: PRINCIPAL_INVESTIGATOR

Western University, Canada

Locations

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The Ohio State University

Columbus, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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M Broich

Role: CONTACT

Other Identifiers

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CLP-008

Identifier Type: -

Identifier Source: org_study_id

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