China 3T MRI Study

Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Study ID
NCT06038123
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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)

Study Details

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.

Key Dates

Start date
Nov 28, 2023
Status verified
Oct 2024
Primary completion
Oct 17, 2024
Completion
Oct 28, 2024

Study Design

Enrollment
64 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

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. ]

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