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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by Transoma Medical.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00717106
First Posted: July 16, 2008
Last Update Posted: May 5, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Transoma Medical
  Purpose
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.

Condition
Syncope Presyncope Fainting Cardiac Arrhythmia

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

Further study details as provided by Transoma Medical:

Primary Outcome Measures:
  • Time to diagnosis [ Time Frame: one year ]

Estimated Enrollment: 250
Study Start Date: July 2008
  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00717106


Locations
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
Investigators
Study Director: Wim Stegink Transoma Medical
  More Information

Responsible Party: Wim Stegink, Transoma Medical
ClinicalTrials.gov Identifier: NCT00717106     History of Changes
Other Study ID Numbers: CLP-007
First Submitted: July 14, 2008
First Posted: July 16, 2008
Last Update Posted: May 5, 2009
Last Verified: May 2009

Keywords provided by Transoma Medical:
ILR
ECG monitoring
cardiac arrhythmia
syncope
presyncope
fainting

Additional relevant MeSH terms:
Syncope
Arrhythmias, Cardiac
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Pathologic Processes