A Clinical Evaluation of the Safety and Efficacy of St. Jude Medical (SJM) Magnetic Resonance Imaging (MRI) Conditional Pacing System in Patients Undergoing Cardiac MRI
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Medical Devices
- Enrollment
- 283
- Locations
- 13
- Primary Endpoint
- Freedom From MRI Scan-related Complications
Study Overview
Brief Summary
The aim of this study was to assess safety and efficacy of SJM MRI conditional pacing system. The study hypothesized that cardiac MRI scan would not affect performance of SJM MRI conditional pacing system.
Detailed Description
Accent Cardiac MRI study was a prospective, randomized ,multi-center study conducted in Asia. Subjects indicated for dual-chamber pacemaker and who signed study consent form were considered enrolled and post implant were randomized to either Cardiac MRI Scan Group or Control Group.
Clinical evaluation and device interrogation were performed at baseline, pre- and post-MRI scan, and one month post-MRI for all subjects. At 9-12 weeks post-implant, patients in Cardiac MRI Scan Group underwent an elective non-diagnostic cardiac MRI scan at 1.5 Tesla (T) while patients in Control group underwent device interrogation and clinical evaluation twice with a 45-minute waiting period in between. The safety endpoint was freedom from MRI-related complications while efficacy endpoint was change in right atrial/ ventricular (RA/RV) capture threshold and sensing amplitude from pre-MRI scan to one month post-MRI scan.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Control Group
Cardiac MRI Scan Group
Intervention: Non-Diagnostic Cardiac MRI scan (Diagnostic Test)
Outcomes
Primary Outcomes
Freedom From MRI Scan-related Complications
Time Frame: MRI Visit ,1 Month Post MRI Visit
Number of subjects who were free from MRI scan-related complications
Change in Right Atrial (RA) Capture Threshold @0.5 Millisecond (ms) From Pre-MRI Scan to 1 Month After MRI Scan
Time Frame: MRI Visit ,1 Month Post MRI Visit
Number of subjects who experienced an increase in RA capture threshold @ 0.5 ms at 1-Month post MRI scan visit ≤ 0.5 Volt (V) compared to pre-MRI scan value collected at MRI scan visit
Change in Right Ventricular (RV) Capture Threshold @0.5ms From Pre-MRI Scan to 1 Month After MRI Scan
Time Frame: MRI Visit, 1 Month Post MRI Visit
Number of subjects who experienced an increase in RV capture threshold @ 0.5 ms at 1-Month post MRI scan visit ≤ 0.5 V compared to pre-MRI scan value collected at MRI scan visit
Change in RA Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan
Time Frame: MRI Visit, 1 Month Post MRI Visit
Number of subjects who experienced a decrease in RA sensing amplitude ≤ 50% and at least 1.5 mV at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit
Change in RV Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan
Time Frame: MRI Visit, 1 Month Post MRI Visit
Number of subjects who experienced a decrease in RV sensing amplitude ≤ 50% and at least 5 mV at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit
Secondary Outcomes
No secondary outcomes reported