Feasibility Study: Sleuth Monitoring System

N/AUnknownNCT00719277

Transoma Medical40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Arrhythmia Syncope

Interventions

Sleuth Implantable ECG Monitoring SystemDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital Paitilla

Panama City, Panama

Outcomes

Primary Outcomes

Diagnostically viable ECG signals

Time frame: daily

Secondary Outcomes

rate of device-related adverse events

Time frame: 1, 6, and 12 months

Data from ClinicalTrials.gov

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