China 3T MRI Study

NCT06038123 | Completed Results

• 1 other identifier: MDT23009
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 5

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. 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The Changes in Atrial and Ventricular Pacing Capture Thresholds From Pre-MRI to 1-month Post-MRI Scan.

  The evaluation will be compared from pre-MRI to 1-month post-MRI scan

Study Arms (1)

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.

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

Interventions

China market released 3.0T Magnetic resonance (MR) conditional CIED systems DEVICE

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)

Subjects with market released 3.0T conditional CIED systems undergoing 3.0T MRI scan attempt

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (5)

Nanfang Hospital Southern Medical University

Guangzhou, Guangdong, China

Location

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

Location

Shanghai Tongren Hospital

Shanghai, Shanghai Municipality, China

Location

Shanxi Cardiovascular Hospital

Taiyuan, Shanxi, China

Location

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Location

MeSH Terms

Conditions

Bradycardia; Tachycardia; Heart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Conduction System Disease

Results Point of Contact

• Title: Peter Tang, Principal Clinical Research Specialist
• Organization: Medtronic

peter.tang@medtronic.com

862138986622

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 14, 2023
• Study Start: November 28, 2023
• Primary Completion: October 17, 2024
• Study Completion: October 28, 2024
• Last Updated: January 14, 2026
• Results First Posted: January 14, 2026

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)