NCT00719277

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

May 5, 2009

Status Verified

May 1, 2009

Enrollment Period

2.6 years

First QC Date

July 17, 2008

Last Update Submit

May 4, 2009

Conditions

ArrhythmiaSyncope

Keywords

cardiac arrhythmiasyncopeECGimplantable ECG monitorILR

Outcome Measures

Primary Outcomes (1)

  • Diagnostically viable ECG signals

    daily

Secondary Outcomes (1)

  • rate of device-related adverse events

    1, 6, and 12 months

Interventions

Sleuth Implantable ECG Monitoring SystemDEVICE

The study device provides monitoring only. It cannot provide intervention or treatment.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Life expectancy \< 12 months following enrollment
  • Active infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Paitilla

Panama City, Panama

Location

MeSH Terms

Conditions

Arrhythmias, CardiacSyncope

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Study Officials

  • Wim Stegink

    Transoma Medical

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 17, 2008

First Posted

July 21, 2008

Study Start

December 1, 2006

Primary Completion

July 1, 2009

Study Completion

September 1, 2009

Last Updated

May 5, 2009

Record last verified: 2009-05

Locations

PA(1)