Arhythmia, Atrioventricular Heart-block, Carotid Sinus Hypersensitivity Reaction Syndrome, Chronic Bundle Branch or Branch Block, Vasovagal Syncope
Conditions
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.
Interventions
DEVICEImageReady™ MR Conditional Pacing System
Sponsors
Boston Scientific Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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
| Measure | Time frame | Description |
|---|---|---|
| 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%. |
Countries
China
Participant flow
Recruitment details
The recruitment has finished on 25 Dec 2015 and totally 10 patients.
Participants by arm
| Arm | Count |
|---|---|
| ImageReady™ System Indication 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
ImageReady™ MR Conditional Pacing System | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | ImageReady™ System Indication |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 69.4 Year |
| Region of Enrollment China | 10 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 2 / 10 |
| serious Total, serious adverse events | 1 / 10 |
Outcome results
Primary
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.
Time frame: Pre-MR scan and 1 Month post-MR Scan.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ImageReady™ MR System Indication | 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 | 100 percentage of participants |
Primary
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%.
Time frame: Pre-MR scan and 1 Month post-MR Scan.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ImageReady™ MR System Indication | 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 | 100 percentage of paticipants |
Primary
Percentage of Participants Without Complications at MRI Visit + 1 Month.
No one has any complications related MR Scan . So Complication-Free rate is 100%.
Time frame: Within 1 month after the Pacemaker been implanted.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ImageReady™ MR System Indication | Percentage of Participants Without Complications at MRI Visit + 1 Month. | 100 percentage of paticipants |
Primary
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%.
Time frame: Pre-MR scan and 1 Month post-MR Scan.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ImageReady™ MR System Indication | 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. | 100 percentage of paticipants |
Secondary
Percentage of Participants Without System-related Complications
No one has any complications related system occurred. So Complication-Free rate is 100%.
Time frame: Within 3 months after the Pacemaker been implanted.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ImageReady™ MR System Indication | Percentage of Participants Without System-related Complications | 100 percentage of paticipants |