Recruiting

Sleuth Implantable Loop Recorder

Sponsor:

Transoma Medical

Code:

NCT00861133

Conditions

Cryptogenic Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sleuth AT Implantable ECG Monitoring System

Study Details

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.

Conditions

Cryptogenic Stroke

Study ID

NCT00861133

Start date

Mar, 2009

Status verified date

May, 2009

Completion date

May, 2011

Anticipated

Primary completion date

Apr, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Interventions

Sleuth AT Implantable ECG Monitoring System

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

Primary outcome measure

  • Incidence of atrial fibrillation at one year from Sleuth implantation. [ Time Frame: One Year ]

Central Contacts and Locations

Central contacts

M Broich

mbroich@transomamedical.com

Locations

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

More Information

Sponsor

Transoma Medical

Last update posted

May 5, 2009

Last verified

May, 2009

Keywords

  • cardiac monitor
  • loop recorder
  • stroke
  • ECG
  • Implantable Loop Recorder
  • cryptogenic
  • ILR

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Transoma Medical on 2009-05-05.