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Feasibility Study: Sleuth Monitoring System (PULSE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Transoma Medical.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Transoma Medical
ClinicalTrials.gov Identifier:
NCT00719277
First received: July 17, 2008
Last updated: May 4, 2009
Last verified: May 2009
History of Changes
  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: Open Label
Primary Purpose: Diagnostic
Official Title: Pilot Clinical Study of the Sleuth Implantable ECG Monitoring System

Resource links provided by NLM:

MedlinePlus related topics: Arrhythmia Fainting
U.S. FDA Resources

Further study details as provided by Transoma Medical:

Primary Outcome Measures:
  • Diagnostically viable ECG signals [ Time Frame: daily ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00719277

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

No publications provided

Responsible Party: Wim Stegink, Transoma Medical
ClinicalTrials.gov Identifier: NCT00719277     History of Changes
Other Study ID Numbers: CLP-005
Study First Received: July 17, 2008
Last Updated: May 4, 2009
Health Authority: Panama: Ministry of Health

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

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Syncope
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Unconsciousness
 Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013