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Clinical Trials/NCT00719277
NCT00719277
Unknown
Not Applicable

Pilot Clinical Study of the Sleuth Implantable ECG Monitoring System

Transoma Medical1 site in 1 country40 target enrollmentDecember 2006
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ConditionsArrhythmiaSyncope

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arrhythmia
Sponsor
Transoma Medical
Enrollment
40
Locations
1
Primary Endpoint
Diagnostically viable ECG signals
Last Updated
17 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
December 2006
End Date
September 2009
Last Updated
17 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Diagnostically viable ECG signals

Time Frame: daily

Secondary Outcomes

  • rate of device-related adverse events(1, 6, and 12 months)

Study Sites (1)

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