Feasibility Study: Sleuth Monitoring System
This trial is active, not recruiting.
|Treatment||sleuth implantable ecg monitoring system|
|Start date||December 2006|
|End date||July 2009|
|Trial size||40 participants|
|Trial identifier||NCT00719277, CLP-005|
The purpose of the study is to evaluate the safety and performance of the Sleuth Monitoring system.
|Intervention model||single group assignment|
Diagnostically viable ECG signals
time frame: daily
rate of device-related adverse events
time frame: 1, 6, and 12 months
Male or female participants at least 18 years old.
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
|Official title||Pilot Clinical Study of the Sleuth Implantable ECG Monitoring System|
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