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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

July 14, 2008
May 4, 2009
July 2008
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Time to diagnosis [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00717106 on ClinicalTrials.gov Archive Site
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Observational Study of the Sleuth Implantable ECG Monitoring System
Observational Study of the Sleuth Implantable ECG Monitoring System

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

cardiology or primary care clinics

  • Syncope
  • Presyncope
  • Fainting
  • Cardiac Arrhythmia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
250
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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
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00717106
CLP-007
No
Wim Stegink, Transoma Medical
Transoma Medical
Not Provided
Study Director: Wim Stegink Transoma Medical
Transoma Medical
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP