We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Feasibility Study: Sleuth Monitoring System (PULSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00719277
Recruitment Status : Unknown
Verified May 2009 by Transoma Medical.
Recruitment status was:  Active, not recruiting
First Posted : July 21, 2008
Last Update Posted : May 5, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of the study is to evaluate the safety and performance of the Sleuth Monitoring system.

Condition or disease Intervention/treatment
Arrhythmia Syncope Device: Sleuth Implantable ECG Monitoring System

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Clinical Study of the Sleuth Implantable ECG Monitoring System
Study Start Date : December 2006
Estimated Primary Completion Date : July 2009
Estimated Study Completion Date : September 2009
Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. Diagnostically viable ECG signals [ Time Frame: daily ]

Secondary Outcome Measures :
  1. rate of device-related adverse events [ Time Frame: 1, 6, and 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  • Life expectancy < 12 months following enrollment
  • Active infection
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00719277


Locations
Panama
Hospital Paitilla
Panama city, Panama
Sponsors and Collaborators
Transoma Medical
Investigators
Study Director: Wim Stegink Transoma Medical
More Information

Responsible Party: Wim Stegink, Transoma Medical
ClinicalTrials.gov Identifier: NCT00719277     History of Changes
Other Study ID Numbers: CLP-005
First Posted: July 21, 2008    Key Record Dates
Last Update Posted: May 5, 2009
Last Verified: May 2009

Keywords provided by Transoma Medical:
cardiac arrhythmia
syncope
ECG
implantable ECG monitor
ILR

Additional relevant MeSH terms:
Syncope
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms