Feasibility Study: Sleuth Monitoring System

Not Applicable

• Conditions: Arrhythmia; Syncope

• 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

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2008-07-17
• Study First Submitted QC: 2008-07-17
• Study First Posted: 2008-07-21
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-04
• Last Update Posted: 2009-05-05
• Primary Completion: 2009-07
• Study Completion: 2009-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

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

Trial Locations

Locations (1)

Hospital Paitilla; 🇵🇦 Panama city, Panama