To evaluate the MRI conditional pacemaker by performing MRI Scanning procedure.
- Conditions
- Health Condition 1: null- Complete Heart Block
- Registration Number
- CTRI/2015/02/005588
- Lead Sponsor
- St Jude Medical India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 252
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
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
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method