Cryptogenic Stroke Study

This study is currently recruiting participants.

Verified by Transoma Medical, May 2009

First Received: March 12, 2009 Last Updated: May 4, 2009 History of Changes

Sponsored by:	Transoma Medical
Information provided by:	Transoma Medical
ClinicalTrials.gov Identifier:	NCT00861133

Purpose

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.

Condition	Intervention
Cryptogenic Stroke	Device: Sleuth AT Implantable ECG Monitoring System

Genetics Home Reference related topics: familial atrial fibrillation

MedlinePlus related topics: Atrial Fibrillation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Single Group Assignment
Official Title:	Long-Term Cardiac Monitoring for Detection of Atrial Fibrillation After Cryptogenic Stroke

Further study details as provided by Transoma Medical:

Primary Outcome Measures:

Incidence of atrial fibrillation at one year from Sleuth implantation. [ Time Frame: One Year ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	March 2009
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00861133

Contacts

Contact: M Broich

mbroich@transomamedical.com

Locations

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

Sponsors and Collaborators

Transoma Medical

Investigators

Principal Investigator:

Andrew Krahn, MD

University of Western Ontario, Canada

More Information

No publications provided

Responsible Party:	Tranoma Medical ( Wim Stegink )
Study ID Numbers:	CLP-008
Study First Received:	March 12, 2009
Last Updated:	May 4, 2009
ClinicalTrials.gov Identifier:	NCT00861133 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Transoma Medical:

cardiac monitor
loop recorder
stroke
ECG

Implantable Loop Recorder
cryptogenic
ILR

Study placed in the following topic categories:

Cerebral Infarction
Stroke
Vascular Diseases
Brain Ischemia
Central Nervous System Diseases
Ischemia

Brain Infarction
Atrial Fibrillation
Brain Diseases
Infarction
Cerebrovascular Disorders

Additional relevant MeSH terms:

Cerebral Infarction
Nervous System Diseases
Stroke
Vascular Diseases
Brain Ischemia

Central Nervous System Diseases
Cardiovascular Diseases
Brain Infarction
Brain Diseases
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on May 07, 2009