Feasibility Study: Sleuth Monitoring System - Full Text View

Sponsored by:	Transoma Medical
Information provided by:	Transoma Medical
ClinicalTrials.gov Identifier:	NCT00719277

Purpose

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

Condition	Intervention
Arrhythmia Syncope	Device: Sleuth Implantable ECG Monitoring System

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Arrhythmia Fainting

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Single Group Assignment
Official Title:	Pilot Clinical Study of the Sleuth Implantable ECG Monitoring System

Further study details as provided by Transoma Medical:

Primary Outcome Measures:

Diagnostically viable ECG signals [ Time Frame: daily ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

rate of device-related adverse events [ Time Frame: 1, 6, and 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	December 2006
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Intervention Details:

The study device provides monitoring only. It cannot provide intervention or treatment.

Eligibility

Criteria

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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719277

Locations

Sponsors and Collaborators

Transoma Medical

Investigators

Study Director:

Dennis Crane

Transoma Medical

More Information

Sponsor website This link exits the ClinicalTrials.gov site

Responsible Party:	Transoma Medical ( VP Clinical Affairs )
Study ID Numbers:	CLP-005
Study First Received:	July 17, 2008
Last Updated:	July 17, 2008
ClinicalTrials.gov Identifier:	NCT00719277
Health Authority:	Panama: Ministry of Health

Keywords provided by Transoma Medical:

cardiac arrhythmia
syncope
ECG
implantable ECG monitor
ILR

Study placed in the following topic categories:

Signs and Symptoms
Unconsciousness
Heart Diseases
Consciousness Disorders

Neurologic Manifestations
Neurobehavioral Manifestations
Syncope
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 13, 2009