EMRI SureScan™ Clinical Study

Study Overview
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Brief Summary
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The purpose of this clinical study is to confirm safety and efficacy in the clinical magnetic resonance imaging (MRI) environment of the investigational EnRhythm MRI™ SureScan™ Pacing System (used in support of Revo MRI™ SureScan Pacing System launch).

Detailed Description
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This study is a prospective, multi-center global study.

Official Title
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EnRhythm MRI™ SureScan™ Pacing System Clinical Investigation

Conditions
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Bradycardia, Slow Heart Beat

Intervention / Treatment
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* Device: Implantable Pulse Generator (IPG) and Pacing Leads (wires)
* Other: Magnetic Resonance Imaging (MRI) scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has, or is at risk of having, a heart beat that is too slow and his/her doctor has determined he/she needs a pacemaker. Subject available for follow-up at study center for length of study. Subject able and willing to undergo elective MRI scanning without sedation. Exclusion Criteria: Subject has, or is at risk of having, a heart beat that is too fast and his/her doctor has determined he/she needs an implantable cardioverter defibrillator (ICD). Subject needs or will need another MRI-scan, other than those required by the study, during the required study follow-up period. Pregnant women, or women of child bearing potential who are not on a reliable form of birth control. Subject with exclusion criteria required by local law. Subject who intends to participate in another clinical study during this clinical study.
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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MRI group<br>The MRI group underwent a one-hour MRI scan at the 9-12 weeks post-implant follow-up. | Device: Implantable Pulse Generator (IPG) and Pacing Leads (wires)<br>* Pacer and leads<br>Other: Magnetic Resonance Imaging (MRI) scan<br>* One hour MRI scan on the head and lower back.<br>|
| Other: Control group<br>The control group waited for one hour (no MRI) at the 9-12 weeks post-implant follow-up. | Device: Implantable Pulse Generator (IPG) and Pacing Leads (wires)<br>* Pacer and leads<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Magnetic Resonance Imaging (MRI)-Related Complications | Subjects with a complication related to the MRI scan. All adverse events in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee. The committee determined whether each adverse event was a complication (requiring invasive intervention), and whether the event was related to the MRI scan. | MRI scan to one-month post-MRI scan | 
| Atrial Pacing Capture Threshold Success | Subjects' atrial pacing capture threshold (the energy sent from the pacemaker needed to make the heart's atrium beat) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their pacing capture threshold did not increase by 1.0 volt (V) or more. | 9-12 week visit to 4-month visit | 
| Ventricular Pacing Capture Threshold Success | Subjects' ventricular pacing capture threshold (the energy sent from the pacemaker needed to make the heart's ventricle beat) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their pacing capture threshold did not increase by 1.0 volt (V) or more. | 9-12 week visit to 4-month visit | 
| Atrial Sensed Amplitude Success | Subjects' atrial sensed amplitude (the minimum energy produced by the heart's atrium that the pacemaker can sense) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their sensed amplitude did not decrease by more than 50% and remained above 1.5 millivolts (mV). | 9-12 week visit to 4-month visit | 
| Ventricular Sensed Amplitude Success | Subjects' ventricular sensed amplitude (the minimum energy produced by the heart's ventricle that the pacemaker can sense) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their sensed amplitude did not decrease by more than 50% and remained above 5.0 millivolts (mV). | 9-12 week visit to 4-month visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects With System-related Complications | Subjects with a complication related to the implanted system, which consisted of the pacemaker, leads to the right chambers of the heart (atrium and ventricle), pacemaker software, and programmer. All adverse events in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee. The committee determined whether each adverse event was a complication (requiring invasive intervention), and whether the event was related to the system. | Implant to 4 Months | 
| System Related Adverse Device Effects Due to Labeling Instructions | Number of participants with adverse device effects (ADEs) that resulted from insufficiencies or inadequacies in the instructions for use or deployment of the device, or from user error. ADE's were investigator-reported. | Implant through 18 months post-implant | 
| Occurrence of Arrhythmias | Number of participants with sustained ventricular arrhythmias or asystole episodes that occurred during the MRI scan that were considered attributable to the MRI scan | During the MRI scan | 
| Atrial Lead Impedance Change | Subjects' atrial lead impedance (a measure of electrical resistance) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Both measurements were conducted by the pacemaker. The difference between the two is reported. | 9-12 week visit and 4-month visit | 
| Ventricular Lead Impedance Change | Subjects' ventricular lead impedance (a measure of electrical resistance) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Both measurements were conducted by the pacemaker. The difference between the two is reported. | 9-12 week visit and 4-month visit | 
| Atrial Lead Handling Rating | Physicians' rated atrial lead handling during the implant on a scale of -3 to +3 where: -3 = well below expectations; -2 = moderately below expectations; -1 = slightly below expectations; 0 = met expectations; +1 = slightly above expectations; +2 = moderately above expectations; and +3 = well above expectations. | During implant | 
| Ventricular Lead Handling Rating | Physicians' rated ventricular lead handling during the implant on a scale of -3 to +3 where: -3 = well below expectations; -2 = moderately below expectations; -1 = slightly below expectations; 0 = met expectations; +1 = slightly above expectations; +2 = moderately above expectations; and +3 = well above expectations. | During implant | 
| Atrial Pacing Capture Threshold | Average atrial pacing capture threshold. Pacing capture threshold is the energy needed to pace the heart. | 3 or 4 months post-implant | 
| Ventricular Pacing Capture Threshold | Average ventricular pacing capture threshold. Pacing capture threshold is the energy needed to pace the heart. | 3 or 4 months post-implant | 
| Atrial Sensed Amplitude | Average atrial sensed amplitude. | 3 or 4 months post-implant | 
| Ventricular Sensed Amplitude | Average ventricular sensed amplitude. | 3 or 4 months post-implant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bradycardia, Slow heart beat, Magnetic resonance imaging (MRI)