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

Transoma Medical

Status: Unknown

Conditions: Syncope; Cardiac Arrhythmia; Presyncope; Fainting

Study type: Observational

Funder types: Industry

Identifiers

NCT00717106

CLP-007

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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