Trial Outcomes & Findings for Observation of ImageReady™ MR Conditional Pacing System in China (NCT NCT02636712)
NCT ID: NCT02636712
Last Updated: 2020-04-08
Results Overview
No one has any complications related MR Scan . So Complication-Free rate is 100%.
Recruitment status
COMPLETED
Target enrollment
10 participants
Primary outcome timeframe
Within 1 month after the Pacemaker been implanted.
Results posted on
2020-04-08
Participant Flow
The recruitment has finished on 25 Dec 2015 and totally 10 patients.
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Observation of ImageReady™ MR Conditional Pacing System in China
Baseline characteristics by cohort
| Measure |
ImageReady™ System Indication
n=10 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=99 Participants
|
|
Age, Continuous
|
69.4 Year
n=99 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
|
Region of Enrollment
China
|
10 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Within 1 month after the Pacemaker been implanted.No one has any complications related MR Scan . So Complication-Free rate is 100%.
Outcome measures
| Measure |
ImageReady™ MR System Indication
n=10 Participants
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
|
|---|---|
|
Percentage of Participants Without Complications at MRI Visit + 1 Month.
|
100 percentage of paticipants
Interval 69.2 to 100.0
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
ImageReady™ MR System Indication
n=10 Participants
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
|
|---|---|
|
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
Interval 80.5 to 100.0
|
PRIMARY outcome
Timeframe: 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%.
Outcome measures
| Measure |
ImageReady™ MR System Indication
n=10 Participants
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
|
|---|---|
|
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
Interval 59.0 to 100.0
|
PRIMARY outcome
Timeframe: 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%.
Outcome measures
| Measure |
ImageReady™ MR System Indication
n=10 Participants
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
|
|---|---|
|
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
Interval 69.2 to 100.0
|
SECONDARY outcome
Timeframe: Within 3 months after the Pacemaker been implanted.No one has any complications related system occurred. So Complication-Free rate is 100%.
Outcome measures
| Measure |
ImageReady™ MR System Indication
n=10 Participants
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
|
|---|---|
|
Percentage of Participants Without System-related Complications
|
100 percentage of paticipants
Interval 69.2 to 100.0
|
Adverse Events
ImageReady™ MR Conditional Pacing System
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ImageReady™ MR Conditional Pacing System
n=10 participants at risk
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
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
10.0%
1/10 • Number of events 1 • Pre-Discharge, MR Scan Visit, MRI Visit+1 Week, MRI Visit+1 Month
|
Other adverse events
| Measure |
ImageReady™ MR Conditional Pacing System
n=10 participants at risk
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
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
10.0%
1/10 • Number of events 1 • Pre-Discharge, MR Scan Visit, MRI Visit+1 Week, MRI Visit+1 Month
|
|
General disorders
Chest pain
|
10.0%
1/10 • Number of events 1 • Pre-Discharge, MR Scan Visit, MRI Visit+1 Week, MRI Visit+1 Month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place