Health Condition 1: null- Patients implanted with an SJM ICD with ST Monitoring and ShockGuardâ?¢ features
Conditions
Interventions
Intervention1: ST Monitoring algorithm: The ST monitoring algorithm SJM ICD allows continuous recording of ST segment changes.
Sponsors
SJM International Inc
St Jude Medical India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: The patient is implanted with an SJM ICD with ST Monitoring and ShockGuard• features (and remote care feature in case Merlin.net will be used);The patient, in the opinion of the investigator, will not require ventricular pacing for more than 20% of the time; The patient, in the opinion of the investigator, has or is at high risk of CAD; The patient is of or above 18 years of age; The patient is able to provide written Informed Consent prior to any investigational related procedure.
Exclusion criteria
Exclusion criteria: The patient has longstanding persistent AF/AFl or permanent AF/AFl; The patient has documented complete heart block; The patient is known to have uncontrolled ventricular bigeminy or trigeminy (PVCs on regular basis); The patient has severe Left Ventricular Hypertrophy resulting in interventricular conduction defect (IVCD);The patient has intermittent bundle branch blocks (BBB); The patient is unable to comply with the follow up schedule; The patient is participating in another investigational device or drug investigation; The patient is pregnant or is planning to become pregnant during the duration of the investigation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the prevalence of device-recorded ST segment changes in the 24 hours preceding appropriate therapies (ATP or shock therapy)Timepoint: All recorded measurements till patient is followed-up in the study. All study subjects will be followed up for a minimum of 12 months. Each subject will remain in the study until the last enrolled subject completes the 12 month follow up visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Among patients having any (appropriate or inappropriate) ICD therapy (shock or ATP) for an arrhythmia, determine the proportion who have device-recorded ST segment changes in the 24 hours before polymorphic VT/VF, and before monomorphic VT. Compare the prevalence of ST segment changes between polymorphic VT/VF to monomorphic VT.Timepoint: Subjects will be followed up for a minimum of 12 months. Each subject will remain in the study until the last enrolled subject completes the 12 month follow up visit.;Among the patients that received ICD shock therapy, determine the number, percentage and type of all inappropriate shocks and characterize the ST segment changes prior to these events when data is available; Comparison of study endpoint analysis against dobutamine stress echo results; Number, duration and results of all ER/hospital visits due to shocks; All-cause hospitalizations; Adverse Events; DeathsTimepoint: Subjects will be followed up for a minimum of 12 months. Each subject will remain in the study until the last enrolled subject completes the 12 month follow up visit. | — |
Countries
Australia, Belgium, Canada, Denmark, India, Japan, New Zealand, United Kingdom
Contacts
Public ContactSumit Anand
St. Jude Medical India Pvt. Ltd.
Outcome results
None listed