Observational Study of the Sleuth Implantable ECG Monitoring System
- Conditions
- FaintingSyncopePresyncopeCardiac Arrhythmia
- Registration Number
- NCT00717106
- Lead Sponsor
- Transoma Medical
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 250
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to diagnosis one year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
Western Maryland Health Systems
🇺🇸Cumberland, Maryland, United States
Cardiology Consultants of East Michigan
🇺🇸Lapeer, Michigan, United States
St. Luke's - Roosevelt
🇺🇸New York, New York, United States
SUMMA-NEOCS Health Systems
🇺🇸Akron, Ohio, United States
Main Line Health - Lankenau Hospital
🇺🇸Wynnewood, Pennsylvania, United States
Center for Cardiac Arrhythmias
🇺🇸Houston, Texas, United States
Morgantown Internal Medicine Group
🇺🇸Morgantown, West Virginia, United States
Piedmont Hospital🇺🇸Atlanta, Georgia, United States