ImageReady(TM) MR Conditional Pacing System Clinical Study

Study Overview
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Brief Summary
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The objective of the SAMURAI Clinical Study is to collect data to confirm the safety, performance and effectiveness of the ImageReady System for use in the Magnetic Resonance Imaging (MRI) environment when used in accordance with the Conditions of Use included in the Boston Scientific MRI Technical Guide

Official Title
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ImageReady(TM) MR Conditional Pacing System Clinical Study

Conditions
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Bradycardia, Sinus Node Dysfunction

Intervention / Treatment
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* Radiation: MRI
* Device: ImageReady System implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must have the ImageReady System as their initial (de novo) pacing system implant Subject has a Class I or II indication for implantation of a single or dual chamber pacemaker according to the ACC/AHA/HRS, or ESC guidelines, as appropriate per geography Subject is able and willing to undergo an MRI scan without intravenous sedation Subject is willing and capable of providing informed consent (which can include the use of a legally authorized representative (LAR) for documentation of informed consent) and participating in all testing/ visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol Subject is age 18 or above, or of legal age to give informed consent specific to state and national law Exclusion Criteria: Subject has or has had any pacing or ICD system implants Subject has any MR Unsafe implants or devices with an unknown MR status, including MR Unsafe sternal wires, neurostimulators, biostimulator, metals or alloys, per labeling of each implant Subject has any MR Conditional implants or devices that impact the ability to conduct this protocol Subject needs or will need another MR scan within 14 weeks of system implant, other than that required by the SAMURAI Study Subject has a known or suspected sensitivity to dexamethasone acetate (DXA) Subject has a mechanical tricuspid heart valve Subject is enrolled in any other concurrent study, with the exception of local mandatory governmental registries and observational studies/registries* that are not in conflict and do not affect the following: Schedule of procedures for the SAMURAI Study (i.e. should not cause additional or missed visits); SAMURAI Study outcome (i.e. involve medications that could affect pacing thresholds); Conduct of the SAMURAI Study per GCP/ ISO 14155:2011/ local regulations Subjects with documented permanent or persistent AF where the physician intends to implant a dual chamber pulse generator (single chamber VVIR pulse generators are acceptable) Subject is currently on the active heart transplant list Subject has documented life expectancy of less than 12 months Women of childbearing potential who are or might be pregnant at the time of study enrollment or ImageReady MR Conditional Pacing System implant (method of assessment upon physician's discretion) Subjects currently requiring dialysis

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRI Group<br>Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant. | Radiation: MRI<br>* The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment<br>* Other names: MR Scan;Device: ImageReady System implant<br>* Pacemaker and lead(s) implant<br>* Other names: Pace/ Sense pacemaker lead implant;|
| Experimental: Control Group<br>Those subjects randomized to the Control Group will not undergo s study-specific MRI scan. All follow-up time requirements are the same for the two groups. | Device: ImageReady System implant<br>* Pacemaker and lead(s) implant<br>* Other names: Pace/ Sense pacemaker lead implant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants Without MR Scan-related Complications | The primary safety endpoint for SAMURAI will be assessed for all subjects randomized to the MRI Group who undergo any portion of the MRI scan sequences. Safety will be confirmed by evaluating the MRI scan-related Complication-free rate (CFR) between the MR Scan and the MRI Visit + 1 Month Visit. | MRI Visit + 1 Month | 
| Success Rate for Threshold Measurement at 1 Month Post-MRI Scan or Control Group Visit | The MRI scan can result in damage to cardiac tissue surrounding lead electrodes due to RF field-induced heating, which in turn may cause elevated pacing thresholds. Primary Effectiveness Endpoint 1 will evaluate any chronic effects from lead heating that will be seen through increased pacing threshold at the MRI Visit + 1 Month follow-up. Subjects with an increase in pacing thresholds s 0.5V (at 0.5 ms) from pre-MR Scan/Control Group visit to MRI/Control visit + 1 Month follow-up were considered a success. A success rate was calculated for both the MRI and the Control Groups. | MRI + 1 Month Visit | 
| Success Rate for Sensed Amplitude Measurement at 1 Month Post-MRI Scan or Control Group Visit | The MRI scan can result in damage to cardiac tissue surrounding lead electrodes due to Radiofrequency (RF) field-induced heating. Primary Effectiveness Endpoint 2 will evaluate any chronic effects from lead heating that will be seen through decreased sensed amplitude at the MRI Visit + 1 Month follow-up. Data were analyzed separately by chamber, Right Atrium (RA) and Right Ventricle (RV), for this endpoint. | MRI + 1 Month Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants Without ImageReady System-related Complications | Overall safety of the ImageReady System will be confirmed by evaluating system-related complications that occur from system implant through 3 months post implant for all subjects who underwent an implant procedure and and reached 91 days of follow-up. | 3 months post implant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, Single chamber pacing, Dual chamber pacing, MR scans