Observation of ImageReady™ MR Conditional Defibrillation System in China

Study Overview
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Brief Summary
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To observe the safety and effectiveness of ImageReady™ MR conditional defibrillation system in a Chinese population.

Detailed Description
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This is a multi-center, prospective, single-arm study, aimed to observe the safety and effectiveness of ImageReady™ MR conditional defibrillation system in a Chinese population.It will enroll 20 subjects in 5 sites in China.The primary safety endpoint is MR scan-related Complication-free rate between the MR Scan and the MRI + 1 Month Visit. The primary effectiveness endpoints include:1.Abnormal increase in RV shocking impedance from the pre-MR scan to the 1 Month post-MR scan. 2.Increase in RV pacing threshold from the pre-MR scan to the 1 Month post-MR scan. 3.Decrease in RV sensed amplitude from the pre-MR scan to the 1 Month post-MR scan. 4.Increase in LV pacing threshold from the pre-MR scan to the 1 Month post-MR scan. 5.Decrease in LV sensed amplitude from the pre-MR scan to the 1 Month post- MR scan.

Official Title
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Observation of ImageReady™ MR Conditional Defibrillation System in China (MR ICD)

Conditions
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Arrhythmia

Intervention / Treatment
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* Device: ImageReady™ MR Conditional Defibrillation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is indicated to Class I/II indications per guidelines/consensus released by Chinese Society of Cardiac Pacing and Electrophysiology Subject must have the ImageReady System as their initial (de novo) defibrillation system implant Subject will receive an ICD or CRT-D pulse generator in the left or right pectoral region ICD Subject is able and willing to undergo an MR scan Subject is willing and capable of providing 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 Exclusion Criteria: Subject has other active or abandoned implanted cardiac rhythm devices, components or accessories present such as pulse generators, leads, lead adaptors or extenders Presence of metallic objects that represent a contraindication to MR imaging at the discretion of the Radiologist and impacting the ability to conduct the study protocol Subject needs or will need a medically necessary MR scan, before completing the 1-month post-MR follow-up visit Subject with: A history of syncope related to brady-arrhythmia A history of syncope of unknown etiology Sinus pauses (Pause > 2 s) Permanent or intermittent complete AV block Documentation of progressive AV nodal block over time Trifascicular block (alternating bundle branch block or PR > 200 ms with LBBB or other bifascicular block) Note: It is required to run a 12 lead ECG and a 10s rhythm strip to document this exclusion criterion. Subject is not clinically capable of tolerating the absence of pacing or Resynchronization therapy support in a supine position for the duration that the pulse generator is in MRI Protection Mode, per Physician discretion Subject is not clinically capable of tolerating the absence of Tachycardia therapy support for the duration that the pulse generator is in MRI Protection Mode, per Physician discretion Subjects currently requiring dialysis Subject has a mechanical heart valve Subject has a known or suspected sensitivity to dexamethasone acetate (DXA) Subject is currently on the active heart transplant list Subject has documented life expectancy of less than 12 months Subject is enrolled in any other concurrent study that might interfere with this study Women of childbearing potential who are or might be pregnant at the time of this study

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ImageReady™ MR Conditional Defibrillation System<br>Subject is indicated to Class I/II indications per guidelines/consensus released by Chinese Society of Cardiac Pacing and Electrophysiology Subject must have the ImageReady System as their initial (de novo) defibrillation system implant | Device: ImageReady™ MR Conditional Defibrillation System<br>* Subject will receive an ICD or CRT-D pulse generator in the left or right pectoral region ICD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percent of Participants Who Were MR Scan-Related ImageReady System Complication -Free | The primary safety endpoint of the MR ICD study will be assessed for all subjects who undergo any portion of the study-required MR scan sequences. Safety will be confirmed by evaluating the MR scan related ImageReady System complication-free rate (CFR) between the MR Scan and the MRI Visit + 1 Month.MR scan related ImageReady System complication is relation with ImageReady System and MR Scan. | MRI + 1 Month Visit（10-13 weeks from 0 day） | 
| The Percentage of Participant Whose the Average RV Shocking Impedance is >200 Ohm 1 Month Post Scan, While it is ≤ 200 Ohm Before Scan | The normal RV shocking impedance measured by the system should be≤200 Ohm, with >200 Ohm considered abnormal. The primary effectiveness endpoint 1 is defined as that the average RV shocking impedance is >200 Ohm at 1 month post scan, while it is ≤ 200 Ohm before scan.There is no hypothesis testing in the MR ICD study, and it can be considered reasonable if up to 2 failed cases of primary effectiveness endpoint 1 occur. | MRI+1 Month visit ( 10 13 weeks from 0 day) | 
| The Percentage of Participant That Have an Increase in Average RV Pacing Thresholds > 0.5V (at 0.5 ms) From Pre-MR Scan to MRI Visit + 1 Month Follow-up | Subjects that have an increase in average RV pacing thresholds ≤ 0.5V (at 0.5 ms) from pre-MR Scan to MRI Visit + 1 Month follow-up will be considered a success, otherwise, it is a primary effectiveness endpoint 2 event.The performance goal of this endpoint for the ENABLE MRI study was 87%. There is no hypothesis testing in the MR ICD study, and it can be considered reasonable if up to 2 failed cases of primary effectiveness endpoint 2 occur. | MRI+1Month visit( 10 14 weeks from 0 day) | 
| The Percentage of Participant That Have the Average RV Sensed Amplitude at the MRI + 1 Month Visit Remains < 5.0 mV or Less Than 50% of the Pre-MR Scan Value | Subjects will be considered a success if the average sensed amplitude at the MRI + 1 Month Visit remains ≥ 5.0 mV and above 50% of the pre-MR scan value, otherwise, it is a primary effectiveness endpoint 3 event.The performance goal of this endpoint for the ENABLE MRI study was 85%. There is no hypothesis testing in the MR ICD study, and it can be considered reasonable if up to 2 failed cases of primary effectiveness endpoint 3 occur. | MR+1 Month visit( 10 14 weeks from 0 day) | 
| The Percentage of Participant Have an Increase in Average LV Pacing Thresholds >1.0V (at 0.5 ms) From Pre-MR Scan to MRI Visit + 1 Month Follow-up | Subjects that have an increase in average LV pacing thresholds ≤1.0V (at 0.5 ms) from pre-MR Scan to MRI Visit + 1 Month follow-up will be considered a success, otherwise, it is a primary effectiveness endpoint 4 event.The performance goal of this endpoint for the ENABLE MRI study was 87%. There is no hypothesis testing in the MR ICD study, and it can be considered reasonable if up to 2 failed cases of primary effectiveness endpoint 4 occur. | MR +1 Month visit( 10 14 weeks from 0 day) | 
| the Percentage of Participant That Have the Average LV Sensed Amplitude at the MRI + 1 Month Visit Remains <5.0 mV or Above 50% of the Pre-MR Scan Value | Subjects will be considered a success if the average sensed amplitude at the MRI + 1 Month Visit remains ≥ 5.0 mV and above 50% of the pre-MR scan value, otherwise, it is a primary effectiveness endpoint 5 event.The performance goal of this endpoint for the ENABLE MRI study was 85%. There is no hypothesis testing in the MR ICD study, and it can be considered reasonable if up to 2 failed cases of primary effectiveness endpoint 5 occur. | MR +1 Month visit( 10 14 weeks from 0 day) |