This trial is active, not recruiting.

Conditions arrhythmia, syncope
Treatment sleuth implantable ecg monitoring system
Sponsor Transoma Medical
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose diagnostic

Primary Outcomes

Diagnostically viable ECG signals
time frame: daily

Secondary Outcomes

rate of device-related adverse events
time frame: 1, 6, and 12 months

Eligibility Criteria

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

Additional Information

Official title Pilot Clinical Study of the Sleuth Implantable ECG Monitoring System
Trial information was received from ClinicalTrials.gov and was last updated in May 2009.
Information provided to ClinicalTrials.gov by Transoma Medical.