A registry (Patient Data Collection) in Patients with Implantable Cardioverter Defibrillator implant.
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Heart Failure
- Registration Number
- CTRI/2009/091/000961
- Lead Sponsor
- St Jude Medical Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- 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 this registry.
Exclusion Criteria
Patient not willing or able to understand and sign the Data Transfer Authorization form.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To identify the population of patients being selected by physicians to be implanted with a St Jude Medical Implantable Cardioverter Defibrillator featuring the ST segment monitoring feature(AnalyST & AnalyST Accel VR/DR devices); 2.document the incidence of ST segment shifts, symptomatic or not, in that population and their possible relationships with clinical events (e.g. cardiac arrhythmias, ICD theray, heart failure hospitalizations).Timepoint: Routine device follow-ups such as 1/3/6/12 Month after implant
- Secondary Outcome Measures
Name Time Method To document the change in patient management related to availability of device diagnostics.Timepoint: Routine device follow-ups such as 1/3/6/12 Month after implant