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NCT00717106 Clinical Trial

Observational Study of the Sleuth Implantable ECG Monitoring System

Syncope Clinical Trial

— OBSERV-ECG  

Official title:
Observational Study of the Sleuth Implantable ECG Monitoring System

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT00717106
Other study ID # CLP-007
Secondary ID
Status Enrolling by invitation
Phase N/A
First received July 14, 2008
Last updated May 4, 2009
Start date July 2008

Study information
Verified date May 2009
Source Transoma Medical
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to obtain information on real-world device performance clinical assessments and clinical outcomes of patients receiving the Sleuth Implantable ECG Monitoring System.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 250
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias

- Patients who experience transient symptoms that may suggest a cardiac arrhythmia

Exclusion Criteria:

- Patients that have had a myocardial infarction (MI) < 30 days prior to implant

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States SUMMA-NEOCS Health Systems Akron Ohio
United States Piedmont Hospital Atlanta Georgia
United States Western Maryland Health Systems Cumberland Maryland
United States Center for Cardiac Arrhythmias Houston Texas
United States Cardiology Consultants of East Michigan Lapeer Michigan
United States Morgantown Internal Medicine Group Morgantown West Virginia
United States St. Luke's - Roosevelt New York New York
United States Main Line Health - Lankenau Hospital Wynnewood Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Transoma Medical

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to diagnosis one year No
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