A clinical evaluation of Patients implanted with Implantable Cardioverter-Defibrillator having Ventricular ArrHyThmias
- Conditions
- Health Condition 1: null- Patients implanted with an SJM ICD with ST Monitoring andShockGuardâ?¢ features
- Registration Number
- CTRI/2012/12/003253
- Lead Sponsor
- SJM International Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 470
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.
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method