MRI Scans in patients implanted with MRI conditional ICD
- Conditions
- Health Condition 1: null- Patient implanted with MRI conditional ICD of St. Jude Medical
- Registration Number
- CTRI/2016/12/007612
- Lead Sponsor
- St Jude Medical India Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 171
To participate in this clinical investigation, the subject must meet all of the following inclusion criteria:
1. Subject is pectorally implanted with St. Jude Medical• MR Conditional ICD System for at least 60 days
2. Subject is willing to undergo an elective MRI scan without sedation
NOTE: Antianxiety agents (e.g. minor tranquilizers, etc.) may be used as long as the patient can communicate with site personnel during the MRI scan
3. Subjectâ??s ventricular bipolar capture threshold is stable < 2.5V @ 0.5ms
4. Subjectâ??s ventricular sensing is measurable (patient has underlying rhythm > 30bpm) and the sensing amplitude is stable > 4mV
5. Subject is able to provide informed consent for study participation (legal guardian or legally authorized representative is NOT acceptable)
6. Subject is willing and able to comply with the prescribed follow-up tests and procedures
7. Subject is not contraindicated for an MRI scan (per the MRI Screening Form)
To participate in this clinical investigation, the subject must meet none of the following exclusion criteria:
1. Subject is pacemaker dependent
2. Subject has a non SJM MRI compatible endocardial lead implanted or capped
3. Subject has another existing active implanted medical device, e.g., neurostimulator, infusion pump, etc. that has MR labeling that will not allow the MRI scans per this protocol to be completed.
4. Subject has a high voltage lead revision incidence < 60 days of the enrollment visit
5. Subject has other non-MRI compatible device or material implanted
NOTE: MRI compatible knee replacements, hip replacements, stents, etc. may be included as long as the labeling of these devices allow MRI scans conducted per this protocol
NOTE: MRI compatible mechanical, prosthetic, and bioprosthetic heart valves may be included as long as the labeling of these devices allow for MRI scans conducted per this protocol
NOTE: Non-removable dental implants may be included
6. Subject has a lead extender, adaptor, or capped/abandoned lead
7. Subject is enrolled or intend to participate in a clinical drug and/or device study (investigational device, investigational drug, new indication for a device or drug or additional testing beyond standard of care procedures), which could confound the results of this trial as determined by SJM.
8. Subject is pregnant or planning to become pregnant during the duration of the subjectâ??s participation in the study
9. Subject has a life expectancy of less than 12 months due to any condition
10. Subject has exclusion criteria required by local law (e.g., age)
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Freedom from MRI Scan related complicationsTimepoint: 1 month post MRI
- Secondary Outcome Measures
Name Time Method â?¢Demographics and medical/surgical history such as gender, age, history of smoking, medical and surgical history and indication for ICD implant, etc. <br/ ><br>â?¢Proportion of SJM high voltage lead implanted with SJM MR Conditional ICD with capture threshold increase of less than or equal to 0.5V @ 0.5ms from pre-MRI scan testing to 1 month post-MRI scan testing & Sensing amplitude decrease of less than or equal to 50% from pre-MRI scan testing to 1 month post-MRI scan testing <br/ ><br>â?¢Adverse EventTimepoint: 1 Month post MRI