Feasibility Study: Sleuth Monitoring System

Pilot Clinical Study of the Sleuth Implantable ECG Monitoring System

The purpose of the study is to evaluate the safety and performance of the Sleuth Monitoring system.

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