Feasibility Study: Sleuth Monitoring System (PULSE)

Transoma Medical

Status: Unknown

Conditions: Syncope; Arrhythmia

Treatments: Device: Sleuth Implantable ECG Monitoring System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00719277

CLP-005

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)