Observational Study of the Sleuth Implantable ECG Monitoring System (OBSERV-ECG)

May 4, 2009 updated by: Transoma Medical
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Hospital
    • Maryland
      • Cumberland, Maryland, United States, 21502
        • Western Maryland Health Systems
    • Michigan
      • Lapeer, Michigan, United States, 48446
        • Cardiology Consultants of East Michigan
    • New York
      • New York, New York, United States, 10019
        • St. Luke's - Roosevelt
    • Ohio
      • Akron, Ohio, United States, 44304
        • SUMMA-NEOCS Health Systems
    • Pennsylvania
      • Wynnewood, Pennsylvania, United States, 19096
        • Main Line Health - Lankenau Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • Center for Cardiac Arrhythmias
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Morgantown Internal Medicine Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

cardiology or primary care clinics

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to diagnosis
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Transoma Medical

Investigators

  • Study Director: Wim Stegink, Transoma Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Study Registration Dates

First Submitted

July 14, 2008

First Submitted That Met QC Criteria

July 15, 2008

First Posted (Estimate)

July 16, 2008

Study Record Updates

Last Update Posted (Estimate)

May 5, 2009

Last Update Submitted That Met QC Criteria

May 4, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLP-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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