Accent Cardiac MRI Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Bradycardia

Intervention / Treatment
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* Diagnostic Test: Non-Diagnostic Cardiac MRI scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Have an approved indication per American College of Cardiology(ACC)/ American Heart Association(AHA)/ Heart Rhythm Society(HRS)/ European Society of Cardiology(ESC) guidelines for implantation of a pacemaker Will receive a new dual chamber pacemaker and leads Be willing to undergo an elective MRI scan without complete sedation, that is ,under consciousness during MRI scan Be able to provide informed consent for study participation Be willing and able to comply with the prescribed follow-up tests and schedule of evaluations Is not contraindicated for an MRI scan (per the pre-MRI safety screening form) Age≥18 years Subjects must be able to undergo pectoral implantation Exclusion Criteria Having an existing pacemaker or Implantable Cardioverter Defibrillator (ICD) .A new pacemaker and lead is required for enrollment Permanent Atrial Fibrillation/Flutter Are medically indicated for an MRI scan at the time of enrollment Have an existing active implanted medical device, e.g. neurostimulator, infusion pump etc Have a non-MRI compatible device or material implanted Have a lead extender or adaptor Be unable to fit in MRI bore; will come into contact with the magnet façade inside the MRI bore Are currently participating in a clinical investigation that includes an active treatment arm Are allergic to dexamethasone sodium phosphate(DSP) Are pregnant or planning to become pregnant during the duration of the study Have a life expectancy of less than 12 months due to any condition Subjects with exclusion criteria required by local law (e.g. age) Are unable to comply with the follow up schedule

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are assigned to one of two groups in parallel for the duration of the study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiac MRI Scan Group<br> | Diagnostic Test: Non-Diagnostic Cardiac MRI scan<br> <br> |
| No Intervention: Control Group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom From MRI Scan-related Complications | Number of subjects who were free from MRI scan-related complications | MRI Visit ,1 Month Post MRI Visit | 
| Change in Right Atrial (RA) Capture Threshold @0.5 Millisecond (ms) From Pre-MRI Scan to 1 Month After MRI Scan | 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 | MRI Visit ,1 Month Post MRI Visit | 
| Change in Right Ventricular (RV) Capture Threshold @0.5ms From Pre-MRI Scan to 1 Month After MRI Scan | 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 | MRI Visit, 1 Month Post MRI Visit | 
| Change in RA Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan | 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 | MRI Visit, 1 Month Post MRI Visit | 
| Change in RV Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan | 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 | MRI Visit, 1 Month Post MRI Visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bradycardia, MRI Conditional Pacemaker, St Jude Medical, Accent MRI Pacemaker, Tendril MRI Lead