Arrhythmia, Syncope
Conditions
Keywords
cardiac arrhythmia, syncope, ECG, implantable ECG monitor, ILR
Brief summary
The purpose of the study is to evaluate the safety and performance of the Sleuth Monitoring system.
Interventions
DEVICESleuth Implantable ECG Monitoring System
The study device provides monitoring only. It cannot provide intervention or treatment.
Sponsors
Transoma Medical
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> = 18 years at time of enrollment * Either of the following: 1. MI \> 30 days prior to enrolment and LVEF \< = 35% by echocardiography (or nuclear imaging as necessary) 2. Syncope of unknown etiology
Exclusion criteria
* Life expectancy \< 12 months following enrollment * Active infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostically viable ECG signals | daily |
Secondary
| Measure | Time frame |
|---|---|
| rate of device-related adverse events | 1, 6, and 12 months |
Countries
Panama
Outcome results
None listed