Observation of ImageReady™ MR Conditional Pacing System in China

Completed

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

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

Detailed Description: Key Inclusion Criteria:

1. Subject must have the Image Ready System as their initial (de novo) pacing system implant.

2. Subject has a Class I or II indication for implantation of a pacemaker according to the CSPE guidelines.

3. Subject is able and willing to undergo an MR scan.•

4. 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.

5. Subject is age 18 or above.

Key Exclusion Criteria

1. Subject has or has had any pacing or ICD system implants.

2. Subject has any implants or devices that are not suitable for MR scan.

3. Subject is enrolled in any other concurrent study that might interfere with this study.

4. Subject has documented life expectancy of less than 12 months.

5. 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:

1. Pacing Threshold (at 0.5 ms pulse width) comparison pre and 1 Month post MR Scan: pacing threshold increase ≤ 0.5 V after scan.

2. Sensed Amplitude comparison pre- and 1 Month post-MR Scan: sensed amplitude: ≥ 1.0 mV after scan, and ≥ 50% of that before scan.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
ImageReady™ MR Conditional Pacing System	ImageReady™ MR Conditional Pacing System	1. Subject must have the ImageReady™ System as their initial (de novo) pacing system implant 2. Subject has a Class I or II indication for implantation of a pacemaker according to the CSPE guidelines

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Without Complications at MRI Visit + 1 Month.	Within 1 month after the Pacemaker been implanted.	No one has any complications related MR Scan . So Complication-Free rate is 100%.
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	Pre-MR scan and 1 Month post-MR Scan.	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%.
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	Pre-MR scan and 1 Month post-MR Scan.	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.
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.	Pre-MR scan and 1 Month post-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%.

Secondary Outcome Measures

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