China 3T MRI Study

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Bradycardia; Tachycardia
• Intervention / Treatment: Device: China market released 3.0T Magnetic resonance (MR) conditional CIED systems

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Nanfang Hospital Southern Medical University
  • Guizhou
    • Zunyi, Guizhou, China
      • Affiliated Hospital of Zunyi Medical University
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Shanghai Tongren Hospital
  • Shanxi
    • Taiyuan, Shanxi, China
      • Shanxi Cardiovascular Hospital
  • Xinjiang
    • Ürümqi, Xinjiang, China
      • The First Affiliated Hospital of Xinjiang Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Subjects with market released 3.0T conditional CIED systems undergoing 3.0T MRI scan attempt; 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.

Device: China market released 3.0T Magnetic resonance (MR) conditional CIED systems; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	The event will be collected within 30 days after MRI visit.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The evaluation will be compared from pre-MRI to 1-month post-MRI scan

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2023
• Primary Completion (Actual): October 17, 2024
• Study Completion (Actual): October 28, 2024

Study Registration Dates

• First Submitted: September 5, 2023
• First Submitted That Met QC Criteria: September 12, 2023
• First Posted (Actual): September 14, 2023

Study Record Updates

• Last Update Posted (Estimated): January 14, 2026
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Heart Failure; Tachycardia; Bradycardia
• Other Study ID Numbers: MDT23009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No