Back to resultsFeasibility Study: Sleuth Monitoring System (PULSE)
Primary Purpose
Arrhythmia, Syncope
Status
Unknown status
Phase
Not Applicable
Locations
Panama
Study Type
Interventional
Intervention
Sleuth Implantable ECG Monitoring System
Sponsored by
About this trial
This is an interventional diagnostic trial for Arrhythmia focused on measuring cardiac arrhythmia, syncope, ECG, implantable ECG monitor, ILR
Eligibility Criteria
Inclusion Criteria:
- Age > = 18 years at time of enrollment
Either of the following:
- MI > 30 days prior to enrolment and LVEF < = 35% by echocardiography (or nuclear imaging as necessary)
- Syncope of unknown etiology
Exclusion Criteria:
- Life expectancy < 12 months following enrollment
- Active infection
Sites / Locations
- Hospital Paitilla
Outcomes
Primary Outcome Measures
Diagnostically viable ECG signals
Secondary Outcome Measures
rate of device-related adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00719277
Brief Title
Feasibility Study: Sleuth Monitoring System
Acronym
PULSE
Official Title
Pilot Clinical Study of the Sleuth Implantable ECG Monitoring System
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
December 2006 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
September 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Transoma Medical
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to evaluate the safety and performance of the Sleuth Monitoring system.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia, Syncope
Keywords
cardiac arrhythmia, syncope, ECG, implantable ECG monitor, ILR
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Sleuth Implantable ECG Monitoring System
Intervention Description
The study device provides monitoring only. It cannot provide intervention or treatment.
Primary Outcome Measure Information:
Title
Diagnostically viable ECG signals
Time Frame
daily
Secondary Outcome Measure Information:
Title
rate of device-related adverse events
Time Frame
1, 6, and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > = 18 years at time of enrollment
Either of the following:
MI > 30 days prior to enrolment and LVEF < = 35% by echocardiography (or nuclear imaging as necessary)
Syncope of unknown etiology
Exclusion Criteria:
Life expectancy < 12 months following enrollment
Active infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wim Stegink
Organizational Affiliation
Transoma Medical
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Paitilla
City
Panama city
Country
Panama
12. IPD Sharing Statement
Learn more about this trial
Feasibility Study: Sleuth Monitoring System
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