NCT00861133

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 13, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

May 5, 2009

Status Verified

May 1, 2009

Enrollment Period

2.1 years

First QC Date

March 12, 2009

Last Update Submit

May 4, 2009

Conditions

Cryptogenic Stroke

Keywords

cardiac monitorloop recorderstrokeECGImplantable Loop RecordercryptogenicILR

Outcome Measures

Primary Outcomes (1)

  • Incidence of atrial fibrillation at one year from Sleuth implantation.

    One Year

Interventions

Sleuth AT Implantable ECG Monitoring SystemDEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Ischemic StrokeStroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Andrew Krahn, MD

    Western University, Canada

    PRINCIPAL INVESTIGATOR

Central Study Contacts

M Broich

CONTACT

mbroich@transomamedical.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 12, 2009

First Posted

March 13, 2009

Study Start

March 1, 2009

Primary Completion

April 1, 2011

Study Completion

May 1, 2011

Last Updated

May 5, 2009

Record last verified: 2009-05

Locations

US(1)