Observational Study of the Sleuth Implantable ECG Monitoring System - Full Text View

Observational Study of the Sleuth Implantable ECG Monitoring System (OBSERV-ECG)

This study is enrolling participants by invitation only.

Sponsored by:	Transoma Medical
Information provided by:	Transoma Medical
ClinicalTrials.gov Identifier:	NCT00717106

Purpose

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.

Condition
Syncope Presyncope Fainting Cardiac Arrhythmia

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Arrhythmia Fainting

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Observational Study of the Sleuth Implantable ECG Monitoring System

Further study details as provided by Transoma Medical:

Primary Outcome Measures:

Time to diagnosis [ Time Frame: one year ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	250
Study Start Date:	July 2008

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

cardiology or primary care clinics

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717106

Locations

United States, Georgia
Piedmont Hospital
Atlanta, Georgia, United States, 30309
United States, Maryland
Western Maryland Health Systems
Cumberland, Maryland, United States, 21502
United States, Michigan
Cardiology Consultants of East Michigan
Lapeer, Michigan, United States, 48446
United States, New York
St. Luke's - Roosevelt
New York, New York, United States, 10019
United States, Ohio
SUMMA-NEOCS Health Systems
Akron, Ohio, United States, 44304
United States, Pennsylvania
Main Line Health - Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
United States, Texas
Center for Cardiac Arrhythmias
Houston, Texas, United States, 77030
United States, West Virginia
Morgantown Internal Medicine Group
Morgantown, West Virginia, United States, 26505

Sponsors and Collaborators

Transoma Medical

Investigators

Study Director:

Wim Stegink

Transoma Medical

More Information

Responsible Party:	Transoma Medical ( VP Clinical Affairs )
Study ID Numbers:	CLP-007
Study First Received:	July 14, 2008
Last Updated:	December 22, 2008
ClinicalTrials.gov Identifier:	NCT00717106
Health Authority:	United States: Institutional Review Board

Keywords provided by Transoma Medical:

ILR
ECG monitoring
cardiac arrhythmia

syncope
presyncope
fainting

Study placed in the following topic categories:

Signs and Symptoms
Unconsciousness
Heart Diseases
Consciousness Disorders

Neurologic Manifestations
Neurobehavioral Manifestations
Syncope
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009