Cryptogenic Stroke Study | NCT00861133

Studies
Cryptogenic Stroke Study

NCT00861133

Sponsor

Transoma Medical

Status

Unknown status

Last Update Posted

May 5, 2009Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Cryptogenic Stroke

Interventions

Sleuth AT Implantable ECG Monitoring System

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Apr 2011Estimated

Completion Date

May 2011Estimated

First Submitted Date

Mar 12, 2009

First Submission Date that Met QC Criteria

Mar 12, 2009

First Posted Date

Mar 13, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2009

Last Update Posted Date

May 5, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sleuth AT Implantable ECG Monitoring System	Device	The study device provides monitoring only. It cannot provide intervention or treatment.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
M Broich	Contact			mbroich@transomamedical.com

Overall Officials

Name	Affiliation	Role
Andrew Krahn, MD	Western University, Canada	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Ohio State University	Recruiting	Columbus	Ohio	43210	United States

Condition Browse Module

MeSH Terms

ID	Term
D000083242	Ischemic Stroke
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided