Status:
COMPLETED
China 3T MRI Study
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Bradycardia
Tachycardia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of the China CIED 3.0T MRI Performance Study is to confirm safety of SureScan CIED in the clinical 3.0T MRI environment when subjects receive MRI scans. ll subjects will have required foll...
Eligibility Criteria
Inclusion
- Subjects who were implanted an SureScan system CIED over 6 weeks at the time of signing ICF.
- Subjects who are able and willing to undergo elective MRI scanning without sedation.
- Subjects who were implanted an SureScan system CIED in the pectoral region.
- Subjects who are geographically stable and available for follow-up at the study site for the length of the study.
- Subjects who are at least 18 years of age (or older, if required by local law).
Exclusion
- Subjects who require a legally authorized representative to obtain informed consent.
- Subjects with abandoned or capped leads.
- Subjects who require an indicated MRI scan, other than those specifically described in the China CIED 3.0T MRI performance study, before the 1-month post-MRI follow-up.
- Subjects with a non-MRI compatible device (such as neurostimulators) or material implant (e.g., non-MRI compatible sternal wires, neurostimulators, biostimulators, metals or alloys).
- Subjects with medical conditions that preclude the testing required by the CIP or limit study participation.
- Subjects who are enrolled or intend to participate in another clinical trial (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during the SureScan study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager.
- Female patient who is pregnant, or of childbearing potential and not on a reliable form of birth control. Women of childbearing potential are required to have a negative pregnancy test within seven (7) days prior to device implant.
Key Trial Info
Start Date :
November 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2024
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06038123
Start Date
November 28 2023
End Date
October 28 2024
Last Update
November 1 2024
Active Locations (5)
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1
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong, China
2
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
3
Shanghai Tongren Hospital
Shanghai, Shanghai Municipality, China
4
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, China