Observation of ImageReady™ MR Conditional Pacing System in China

Study Overview
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Brief Summary
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To observe the safety and efficacy of ImageReady™ MR Conditional Pacing System in Chinese subjects

Detailed Description
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Key Inclusion Criteria: Subject must have the Image Ready System as their initial (de novo) pacing system implant. Subject has a Class I or II indication for implantation of a pacemaker according to the CSPE guidelines. 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 the intervals defined by this protocol. Subject is age 18 or above. Key Exclusion Criteria Subject has or has had any pacing or ICD system implants. Subject has any implants or devices that are not suitable for MR scan. Subject is enrolled in any other concurrent study that might interfere with this study. Subject has documented life expectancy of less than 12 months. Women of childbearing potential who are or might be pregnant at the time of this study. Primary Safety Endpoint: MR Scan related Complication Free Rate Analyzed at MRI Visit +1 Month. Primary efficacy Endpoint: Pacing Threshold (at 0.5 ms pulse width) comparison pre and 1 Month post MR Scan: pacing threshold increase ≤ 0.5 V after scan. Sensed Amplitude comparison pre- and 1 Month post-MR Scan: sensed amplitude: ≥ 1.0 mV after scan, and ≥ 50% of that before scan.

Official Title
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Observation of ImageReady™ MR Conditional Pacing System in China

Conditions
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Arhythmia, Atrioventricular Heart-block, Chronic Bundle Branch or Branch Block, Carotid Sinus Hypersensitivity Reaction Syndrome, Vasovagal Syncope

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


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 pacemaker according to the CSPE guidelines5 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 the intervals defined by this protocol Subject is age 18 or above Exclusion Criteria: Subject has or has had any pacing or ICD system implants Subject has any implants or devices that are not suitable for MR scan Subject is enrolled in any other concurrent study that might interfere with this study Subject has documented life expectancy of less than 12 months 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ImageReady™ MR Conditional Pacing System<br>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 pacemaker according to the CSPE guidelines | Device: ImageReady™ MR Conditional Pacing System<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Without Complications at MRI Visit + 1 Month. | No one has any complications related MR Scan . So Complication-Free rate is 100%. | Within 1 month after the Pacemaker been implanted. | 
| Percentage of Participants Reporting an Increase in Pacing Thresholds ≤ 0.5V (at 0.5 ms) From Pre-MR Scan to MRI Visit + 1 Month Follow-up | The percentage of Participants Reporting an Increase in Pacing Thresholds ≤ 0.5V (at 0.5 ms) from Pre-MR Scan to MRI Visit + 1 Month Follow-up is 100 percent. | Pre-MR scan and 1 Month post-MR Scan. | 
| Percentage of Participants With Atrial Sensed Amplitude at the MRI Visit + 1 Month Follow up Remains ≥ 1.0 mV and Above 50% of the Pre-MR Scan Value | The Percentage of participants with atrial sensed amplitude at the MRI Visit + 1 Month Follow up remains ≥ 1.0 mV and above 50% of the pre-MR scan value is 100%. | Pre-MR scan and 1 Month post-MR Scan. | 
| Percentage of Participants With Ventricular Sensed Amplitudes at the MRI Visit + 1 Month Follow up Remains ≥ 5.0 mV and Above 50% of the Pre-MR Scan. | The percentage of participants with ventricular sensed amplitudes at the MRI Visit + 1 Month Follow up remains ≥ 5.0 mV and above 50% of the pre-MR scan is 100%. | Pre-MR scan and 1 Month post-MR Scan. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Without System-related Complications | No one has any complications related system occurred. So Complication-Free rate is 100%. | Within 3 months after the Pacemaker been implanted. |