Observational Study of the Sleuth Implantable ECG Monitoring System
OBSERV-ECG
1 other identifier
observational
250
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 14, 2008
CompletedFirst Posted
Study publicly available on registry
July 16, 2008
CompletedMay 5, 2009
May 1, 2009
July 14, 2008
May 4, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to diagnosis
one year
Eligibility Criteria
cardiology or primary care clinics
You may qualify if:
- Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
- Patients who experience transient symptoms that may suggest a cardiac arrhythmia
You may not qualify if:
- Patients that have had a myocardial infarction (MI) \< 30 days prior to implant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Transoma Medicallead
Study Sites (8)
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Western Maryland Health Systems
Cumberland, Maryland, 21502, United States
Cardiology Consultants of East Michigan
Lapeer, Michigan, 48446, United States
St. Luke's - Roosevelt
New York, New York, 10019, United States
SUMMA-NEOCS Health Systems
Akron, Ohio, 44304, United States
Main Line Health - Lankenau Hospital
Wynnewood, Pennsylvania, 19096, United States
Center for Cardiac Arrhythmias
Houston, Texas, 77030, United States
Morgantown Internal Medicine Group
Morgantown, West Virginia, 26505, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Wim Stegink
Transoma Medical
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 14, 2008
First Posted
July 16, 2008
Study Start
July 1, 2008
Last Updated
May 5, 2009
Record last verified: 2009-05