Feasibility Study: Sleuth Monitoring System
Not Applicable
- Conditions
- ArrhythmiaSyncope
- Registration Number
- NCT00719277
- Lead Sponsor
- Transoma Medical
- Brief Summary
The purpose of the study is to evaluate the safety and performance of the Sleuth Monitoring system.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
-
Age > = 18 years at time of enrollment
-
Either of the following:
- MI > 30 days prior to enrolment and LVEF < = 35% by echocardiography (or nuclear imaging as necessary)
- Syncope of unknown etiology
Exclusion Criteria
- Life expectancy < 12 months following enrollment
- Active infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Diagnostically viable ECG signals daily
- Secondary Outcome Measures
Name Time Method rate of device-related adverse events 1, 6, and 12 months
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of arrhythmia detection in the Sleuth implantable ECG monitoring system?
How does the Sleuth system compare to standard-of-care Holter monitors in syncope patient management?
Are there specific biomarkers associated with arrhythmia subtypes that the Sleuth system can identify?
What adverse events are reported with implantable ECG monitoring systems like Sleuth and how are they managed?
What are the current trends in implantable cardiac monitoring technologies compared to the Sleuth system's approach?
Trial Locations
- Locations (1)
Hospital Paitilla
🇵🇦Panama city, Panama
Hospital Paitilla🇵🇦Panama city, Panama