Health Condition 1: null- Complete Heart Block
Conditions
Interventions
Intervention1: MRI Scan Group: Patient undergoes a Cardiac MRI Scan
Control Intervention1: Control Group: Patient will not undergo Cardiac MRI Scan
Sponsors
St Jude Medical India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Have an approved indication per ACC/AHA/HRS/ESC guidelines for implantation of a pacemaker Will receive a new dual chamber pacemaker and leads Be willing to undergo an elective MRI scan without complete sedation, that is ,under consciousness during MRI scan Be able to provide informed consent for study participation Be willing and able to comply with the prescribed follow-up tests and schedule of evaluations Is not contraindicated for an MRI scan (per the pre-MRI safety screening form) Age greater than equal to 18 years Subjects must be able to undergo pectoral implantation
Exclusion criteria
Exclusion criteria: Having an existing pacemaker or ICD .A new pacemaker and lead is required for enrollment Permanent Atrial Fibrillation/Flutter Are medically indicated for an MRI scan at the time of enrollment Have an existing active implanted medical device, e.g. neurostimulator, infusion pump etc Have a non-MRI compatible device or material implanted Have a lead extender or adaptor Be unable to fit in MRI bore; will come into contact with the magnet façade inside the MRI bore Are currently participating in a clinical investigation that includes an active treatment arm Are allergic to dexamethasone sodium phosphate(DSP) Are pregnant or planning to become pregnant during the duration of the study Have a life expectancy of less than 12 months due to any condition Subjects with exclusion criteria required by local law (e.g.age) Are unable to comply with the follow up schedule
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint Freedom from MRI scan-related complications Change in right atrial/ventricular capture threshold @0.5ms before and 1 month after the MRI scan. Change in right atrial/ventricular sensing amplitude before and 1 month after the MRI scan.Timepoint: 1 month post MRI scan | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in right atrial and right ventricular capture threshold at 0.5ms before and immediately after MRI scan; Change in right atrial and right ventricular sensing amplitude before and immediately after the MRI scan; Change in right ventricular lead & right atrial lead impedance before and immediately as well as 1 month after the MRI scan; Change in right atrial lead impedance before and immediately as well as 1 month after the MRI scanTimepoint: 1 month post MRI scan | — |
Countries
Hong Kong, India, Malaysia, Singapore, Thailand
Contacts
Public ContactSumit Anand
St. Jude Medical India Pvt. Ltd
Outcome results
None listed