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

This study is enrolling participants by invitation only.
Information provided by:
Transoma Medical Identifier:
First received: July 14, 2008
Last updated: May 4, 2009
Last verified: May 2009
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.

Cardiac Arrhythmia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of the Sleuth Implantable ECG Monitoring System

Resource links provided by NLM:

Further study details as provided by Transoma Medical:

Primary Outcome Measures:
  • Time to diagnosis [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: July 2008

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
cardiology or primary care clinics

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00717106

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

Responsible Party: Wim Stegink, Transoma Medical Identifier: NCT00717106     History of Changes
Other Study ID Numbers: CLP-007 
Study First Received: July 14, 2008
Last Updated: May 4, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Transoma Medical:
ECG monitoring
cardiac arrhythmia

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on October 20, 2016