NCT06038123Completed
China 3T MRI Study
China CIED 3.0T MRI Performance Study
Source: ClinicalTrials.gov · Last updated 14 Jan 2026
Brief summary (registry, in English)
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. All subjects will have required follow-up visits at baseline, MRI visit, 1-month post-MRI. The MRI scans will occur at the MRI visit. The MRI scan region will be determined by investigator according to the subject's clinical condition.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 64 (actual)
- First submitted
- 5 Sept 2023
- Start date
- 28 Nov 2023
- Primary completion date
- 17 Oct 2024
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Diseases
- Heart failure
- NCT number
- NCT06038123
What you commit to
- Study type: Interventional
- Participants enrolled: 64
- From 28 Nov 2023 to the primary completion date, 17 Oct 2024
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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.
Other illness
- Subjects with medical conditions that preclude the testing required by the CIP or limit study participation.
Other
- 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.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Shanghai Tongren Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanxi Cardiovascular Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| The First Affiliated Hospital of Xinjiang Medical University Coordinator of this site? Confirm its status | Ürümqi | China | Unknown status |
| Affiliated Hospital of Zunyi Medical University Coordinator of this site? Confirm its status | Zunyi | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.