Cryptogenic Stroke Study

Transoma Medical100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

100

Conditions

Cryptogenic Stroke

Interventions

Sleuth AT Implantable ECG Monitoring SystemDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The Ohio State University

Columbus, Ohio, United States

RECRUITING

Outcomes

Primary Outcomes

Incidence of atrial fibrillation at one year from Sleuth implantation.

Time frame: One Year

Central Contacts

M Broich

CONTACT

mbroich@transomamedical.com

Data from ClinicalTrials.gov

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