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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Transoma Medical
ClinicalTrials.gov Identifier:
NCT00717106
First received: July 14, 2008
Last updated: May 4, 2009
Last verified: May 2009
History of Changes
  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

Resource links provided by NLM:

MedlinePlus related topics: Arrhythmia Fainting
U.S. FDA Resources

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
  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Wim Stegink, Transoma Medical
ClinicalTrials.gov 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:
ILR
ECG monitoring
cardiac arrhythmia
 syncope
presyncope
fainting

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

ClinicalTrials.gov processed this record on May 19, 2013