Feasibility Study: Sleuth Monitoring System

Arrhythmia Clinical Trial

— PULSE  

Official title:

Pilot Clinical Study of the Sleuth Implantable ECG Monitoring System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00719277
• Other study ID #: CLP-005
• Status: Active, not recruiting
• Phase: N/A
• First received: July 17, 2008
• Last updated: May 4, 2009
• Start date: December 2006
• Est. completion date: September 2009

Study information

• Verified date: May 2009
• Source: Transoma Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Panama: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: September 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Arrhythmia
• Syncope

Intervention

Device:
• Sleuth Implantable ECG Monitoring System
The study device provides monitoring only. It cannot provide intervention or treatment.

Locations

Country	Name	City	State
Panama	Hospital Paitilla	Panama city

Sponsors (1)

Lead Sponsor	Collaborator
Transoma Medical

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostically viable ECG signals		daily	No
Secondary	rate of device-related adverse events		1, 6, and 12 months	Yes