Continuous ST Segment Monitoring and Incidence of Clinical Events in Implantable Cardioverter Defibrillator (ICD) Patients

Not Applicable

Completed

• Conditions: Ventricular arrhythmias; Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation; Sinus Node Dysfunction; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12610000041055
• Lead Sponsor: St. Jude Medical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-01-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Any patient candidate implanted with a St Jude Medical AnalyST or AnalyST Accel DR/VR device, as per current guidelines can be enrolled in the study.

Exclusion Criteria

Patient not willing or able to understand and sign the 'data transfer authorization'

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To Identify the population of patients being selected by physicians to be implanted with a SJM ICD featuring ST segment monitoring. This will be assessed through the collection of patients medical history and demographics via the Case Report Forms (CRF's).[Implant date];Document the Incidence of ST segment shifts, symptomatic or not, in the population and their possible relationships with clinical events. This will be achieved through Device interrogation and CRF reporting[12 months post implant, data will be collected at routine visits (max four follow up visits)]

Secondary Outcome Measures

Name	Time	Method
To document the change in patient management related to the availability of device diagnositcs. Physicians will record changes made to medication, device programming or tests/exams ordered on the CRFs.[12months post implant, data collected during routine visits (maximum of four follow up visits)]