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Feasibility Study: Sleuth Monitoring System (PULSE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by Transoma Medical.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00719277
First Posted: July 21, 2008
Last Update Posted: May 5, 2009
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.
Information provided by:
Transoma Medical
  Purpose
The purpose of the study is to evaluate the safety and performance of the Sleuth Monitoring system.

Condition Intervention
Arrhythmia Syncope Device: Sleuth Implantable ECG Monitoring System

Study Type: Interventional
Study Design: 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

Further study details as provided by Transoma Medical:

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

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

Estimated Enrollment: 40
Study Start Date: December 2006
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Sleuth Implantable ECG Monitoring System
    The study device provides monitoring only. It cannot provide intervention or treatment.
  Eligibility

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 Submitted: July 17, 2008
First Posted: July 21, 2008
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