CTRI/2017/05/008447
Completed
未知
Clinical Study to Confirm MRI Safety and Effectiveness Using SJM Cardiac Rhythm Management Systems
St Jude Medical India Ltd0 sites30 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- patients indicated for any one of the following: ICD / CRT-D / Pacemaker
- Sponsor
- St Jude Medical India Ltd
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Eligible subjects will meet all of the following:
- •Are implanted with one of the following SJM device/lead combinations evaluated in this study for at least 60 days (can include patients with an eligible SJM lead for \>\= 60 days OR patients with a new eligible SJM pacemaker, ICD, or CRT device and eligible SJM lead implanted for at least 60 days:
- •1\. Accent MRI•, Assurity MRI•, Endurity MRI•, or Endurity pacemaker with Tendril• STS Model 2088 lead
- •2\. Accent MRI•, Assurity MRI•, Endurity MRI•, or Endurity pacemaker with IsoFlex• Optim (Model 1944 or 1948\) lead
- •3\. Ellipse• VR/DR or Fortify Assura VR/DR ICD with Tendril• STS (Model 2088\) or Tendril MRI• and Durata• or Optisure• leads
- •4\. Quadra Assura• CRT\-D with Tendril• STS (Model 2088\), Durata• or Optisure•, and Quartet• Quadripolar leads
- •Are implanted with an eligible SJM pacemaker, ICD, or CRT\-D device pectorally
- •Be willing to undergo an elective MRI scan without sedation. Note: Antianxiety agents (e.g. minor tranquilizers, etc.) may be used as long as the subject can communicate with site personnel during the MRI scan
- •Be able to provide informed consent for study participation (legal guardian is NOT acceptable)
- •Be willing and able to comply with the prescribed follow\-up tests and schedule of evaluations
Exclusion Criteria
- •Subjects will be excluded if they meet any of the following:
- •Have 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.
- •Have other non\-MRI compatible device or material implanted
- •o 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
- •o 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
- •o NOTE: Non\-removable dental implants may be included
- •Have a lead extender, adaptor, or capped/abandoned lead
- •Be unable to fit in MRI bore, i.e., subject 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 pregnant or planning to become pregnant during the duration of the study
Outcomes
Primary Outcomes
Not specified
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