Feasibility Study: Sleuth Monitoring System

NCT ID: NCT00719277

Last Updated: 2009-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2009-09-30

Brief Summary

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

Detailed Description

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Conditions

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Arrhythmia Syncope

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Sleuth Implantable ECG Monitoring System

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Transoma Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Transoma Medical

Principal Investigators

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Wim Stegink

Role: STUDY_DIRECTOR

Transoma Medical

Locations

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Hospital Paitilla

Panama City, , Panama

Site Status

Countries

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Panama

Other Identifiers

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CLP-005

Identifier Type: -

Identifier Source: org_study_id

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