Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Information provided by:
Transoma Medical Identifier:
First received: July 17, 2008
Last updated: May 4, 2009
Last verified: May 2009

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

Condition Intervention
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:

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00719277

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

No publications provided

Responsible Party: Wim Stegink, Transoma Medical 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
implantable ECG monitor

Additional relevant MeSH terms:
Consciousness Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Unconsciousness processed this record on February 25, 2015