BradycardiaNCT06038123
China 3T MRI Study
A study testing China market released 3.0T Magnetic resonance (MR) conditional CIED systems in people with Bradycardia and Tachycardia, run by Medtronic Cardiac Rhythm and Heart Failure at 5 sites in China.
Trial 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. 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia, Tachycardia, Heart Failure
- What is being tested?
- China market released 3.0T Magnetic resonance (MR) conditional CIED systems
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 5 sitesChina
- Study dates
- 28 Nov 2023to 28 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong
Shanghai Tongren Hospital
Shanghai, Shanghai Municipality
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou
About this study
Official title: China CIED 3.0T MRI Performance Study
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.
- Conditions
- Bradycardia, Tachycardia, Heart Failure
- Being tested
- China market released 3.0T Magnetic resonance (MR) conditional CIED systems
- Medical subject headings
- Bradycardia, Tachycardia, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
China market released 3.0T Magnetic resonance (MR) conditional CIED systemsDevice
To confirm safety and effectiveness of the SureScan CIED System in the clinical MRI environment when subjects receive 3.0T MRI scans without positioning restrictions (MRI scans may occur anywhere on the body)
| Study group | Role | What they receive |
|---|---|---|
| Subjects with market released 3.0T conditional CIED systems undergoing 3.0T MRI scan attempt | Experimental | This was a single-arm study to confirm safety and effectiveness of the SureScan CIED System in the clinical MRI environment when subjects receive 3.0T MRI scans without positioning restrictions (MRI scans may occur anywhere on the body). Study devices refer to China market released 3.0T Magnetic resonance (MR) conditional CIED systems. Subjects implanted with a SureScan study device who underwent a 3.0T MRI scan attempt were considered in endpoint analyses. Receives: Device: China market released 3.0T Magnetic resonance (MR) conditional CIED systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Occurrence of an MRI-related Event for CIED
The primary objective was to demonstrate the safety of SureScan system CIED in clinical 3.0T MRI environment within 1-month post-MRI scan. Specifically, it was hypothesized that the MRI-related event-free rate within 1-month post-MRI to be greater than 90%. The proportion of subjects free from MRI-related events was calculated by dividing the number of subjects without an MRI-related event by the number of subjects at risk for an event. The occurrence of any of the following within 30 days after a 3.0T MRI scan would be considered an MRI-related event: (1) Medical advisor-assessed MRI-related complication within 30 days post-MRI (for iPG, ICD or CRT-D); (2) Medical advisor-assessed right ventricular MRI-related loss of capture within 30 days post-MRI (for iPG, ICD or CRT-D); (3) Sustained tachyarrhythmia originating during SureScan programming, requiring immediate treatment (defined as ATP, device shock, or external shock), as assessed by a medical advisor (for ICD or CRT-D).
Measured: The event will be collected within 30 days after MRI visit.
Secondary outcomes (1)
The Changes in Atrial and Ventricular Pacing Capture Thresholds From Pre-MRI to 1-month Post-MRI Scan.
There was no hypothesis for this secondary objective. Pacing capture thresholds (PCTs) to be characterized include:
APCT of atrial lead for subjects with an IPG device; APCT of atrial lead and VPCT of right ventricular (RV) lead for subjects with an ICD device; APCT of atrial lead and VPCTs of right ventricular (RV) and left ventricular (LV) leads for those with a CRT-D device.
PCTs of each subject will be measured prior to the 3.0T MRI scan and at the one-month post-MRI. Change in PCT is defined as PCT measured at one-month post-MRI subtracts that measured prior to a 3.0T MRI scan. Proportion of subjects with an increase less than or equal to 0.5V in APCT or VPCTs from pre-MRI to one-month post-MRI will also be used to characterize the efficacy performance of SureScan with respect to PCTs. If the 1-month post-MRI APCT or VPCT is missing, the PCT measured immediately post-MRI will be used instead.
Measured: The evaluation will be compared from pre-MRI to 1-month post-MRI scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start28 Nov 2023
- Primary completion17 Oct 2024
- Study completion28 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038123
- Sponsor's protocol ID
- MDT23009
- Status last verified
- Oct 2024
- First submitted
- 5 Sep 2023
- Last updated
- 14 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China CIED 3.0T MRI Performance Study
- ClinicalTrials.gov ID
- NCT06038123
- Acronym / sponsor ID
- MDT23009
- Conditions
- Bradycardia, Tachycardia, Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 17 Oct 2024 (actual)
- Study completion
- 28 Oct 2024 (actual)
- First posted
- 14 Sep 2023 (actual)
- Results
- Posted 14 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with market released 3.0T conditional CIED systems undergoing 3.0T MRI scan attempt | Experimental | Device: China market released 3.0T Magnetic resonance (MR) conditional CIED systemsThis was a single-arm study to confirm safety and effectiveness of the SureScan CIED System in the clinical MRI environment when subjects receive 3.0T MRI scans without positioning restrictions (MRI scans may occur anywhere on the body). Study devices refer to China market released 3.0T Magnetic resonance (MR) conditional CIED systems. Subjects implanted with a SureScan study device who underwent a 3.0T MRI scan attempt were considered in endpoint analyses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| China market released 3.0T Magnetic resonance (MR) conditional CIED systemsTo confirm safety and effectiveness of the SureScan CIED System in the clinical MRI environment when subjects receive 3.0T MRI scans without positioning restrictions (MRI scans may occur anywhere on the body) | Device | Subjects with market released 3.0T conditional CIED systems undergoing 3.0T MRI scan attempt |
Primary outcome
The Occurrence of an MRI-related Event for CIED
Time frame: The event will be collected within 30 days after MRI visit.
The primary objective was to demonstrate the safety of SureScan system CIED in clinical 3.0T MRI environment within 1-month post-MRI scan. Specifically, it was hypothesized that the MRI-related event-free rate within 1-month post-MRI to be greater than 90%. The proportion of subjects free from MRI-related events was calculated by dividing the number of subjects without an MRI-related event by the number of subjects at risk for an event. The occurrence of any of the following within 30 days after a 3.0T MRI scan would be considered an MRI-related event: (1) Medical advisor-assessed MRI-related complication within 30 days post-MRI (for iPG, ICD or CRT-D); (2) Medical advisor-assessed right ventricular MRI-related loss of capture within 30 days post-MRI (for iPG, ICD or CRT-D); (3) Sustained tachyarrhythmia originating during SureScan programming, requiring immediate treatment (defined as ATP, device shock, or external shock), as assessed by a medical advisor (for ICD or CRT-D).
1 secondary outcome
The Changes in Atrial and Ventricular Pacing Capture Thresholds From Pre-MRI to 1-month Post-MRI Scan.
Time frame: The evaluation will be compared from pre-MRI to 1-month post-MRI scan
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing China market released 3.0T Magnetic resonance (MR) conditional CIED systems in people with Bradycardia and Tachycardia, run by Medtronic Cardiac Rhythm and Heart Failure at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Occurrence of an MRI-related Event for CIED (time frame: The event will be collected within 30 days after MRI visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026; AzTrials last refreshed its copy on 26 Oct 2026.