Observational Study of the Sleuth Implantable ECG Monitoring System

NCT ID: NCT00717106

Last Updated: 2009-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Brief Summary

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The purpose of this study is to obtain information on real-world device performance clinical assessments and clinical outcomes of patients receiving the Sleuth Implantable ECG Monitoring System.

Detailed Description

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Conditions

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Syncope Presyncope Fainting Cardiac Arrhythmia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
* Patients who experience transient symptoms that may suggest a cardiac arrhythmia

Exclusion Criteria

* Patients that have had a myocardial infarction (MI) \< 30 days prior to implant
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Transoma Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Transoma Medical

Principal Investigators

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Wim Stegink

Role: STUDY_DIRECTOR

Transoma Medical

Locations

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Piedmont Hospital

Atlanta, Georgia, United States

Site Status

Western Maryland Health Systems

Cumberland, Maryland, United States

Site Status

Cardiology Consultants of East Michigan

Lapeer, Michigan, United States

Site Status

St. Luke's - Roosevelt

New York, New York, United States

Site Status

SUMMA-NEOCS Health Systems

Akron, Ohio, United States

Site Status

Main Line Health - Lankenau Hospital

Wynnewood, Pennsylvania, United States

Site Status

Center for Cardiac Arrhythmias

Houston, Texas, United States

Site Status

Morgantown Internal Medicine Group

Morgantown, West Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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CLP-007

Identifier Type: -

Identifier Source: org_study_id

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