Trial Outcomes & Findings for A Post-market Clinical Evaluation of St. Jude Medical™ MR Conditional ICD System on Patients Undergoing Magnetic Resonance Imaging (NCT NCT02877693)
NCT ID: NCT02877693
Last Updated: 2023-12-08
Results Overview
\*A complication is a serious adverse device effect (SADE) that requires an invasive intervention or leads to death. The primary endpoint analysis will be performed for each study phase separately.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
205 participants
Primary outcome timeframe
from MRI scan visit to 1 month post-MRI scan visit
Results posted on
2023-12-08
Participant Flow
Subject enrollment in the Asia MRI ICD study began on October 10, 2016. The study enrolled 205 subjects at 20 clinical sites. Completion of enrollment and follow-up in the study occurred on March 23, 2020.
Participant milestones
| Measure |
Thoracic MRI Scan With 1.5 Tesla MRI
Subjects will be enrolled at least 60 days post successful St. Jude Medical™ MR Conditional ICD System implant. Enrolled subjects will undergo an elective 1.5T MRI scan within 30 days post enrollment. Post MRI visit all subjects will be followed up at 1-Month post MRI visit.
|
Thoracic MRI Scan With 3 Tesla MRI
Subjects will be enrolled at least 60 days post successful St. Jude Medical™ MR Conditional ICD System implant. Enrolled subjects will undergo an elective 3T MRI scan within 30 days post enrollment. Post MRI visit all subjects will be followed up at 1-Month post MRI visit.
|
|---|---|---|
|
Overall Study
STARTED
|
205
|
0
|
|
Overall Study
COMPLETED
|
177
|
0
|
|
Overall Study
NOT COMPLETED
|
28
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Post-market Clinical Evaluation of St. Jude Medical™ MR Conditional ICD System on Patients Undergoing Magnetic Resonance Imaging
Baseline characteristics by cohort
| Measure |
Thoracic MRI Scan With 1.5 Tesla MRI
n=205 Participants
Subjects will be enrolled at least 60 days post successful St. Jude Medical™ MR Conditional ICD System implant. Enrolled subjects will undergo an elective 1.5T MRI scan within 30 days post enrollment. Post MRI visit all subjects will be followed up at 1-Month post MRI visit.
|
|---|---|
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Age, Continuous
|
61.2 years
STANDARD_DEVIATION 13.1 • n=93 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
173 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
178 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
201 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=93 Participants
|
|
Region of Enrollment
South Korea
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20 participants
n=93 Participants
|
|
Region of Enrollment
Malaysia
|
4 participants
n=93 Participants
|
|
Region of Enrollment
India
|
181 participants
n=93 Participants
|
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Cardiovascular History
Non-ischemic Cardiomyopathy
|
75 Participants
n=93 Participants
|
|
Cardiovascular History
Ischemic Cardiomyopathy
|
93 Participants
n=93 Participants
|
|
Cardiovascular History
No Cardiomyopathy
|
37 Participants
n=93 Participants
|
|
Primary Indication for ICD Implant
Cardiac Arrest
|
22 Participants
n=93 Participants
|
|
Primary Indication for ICD Implant
Ventricular Tachycardia
|
57 Participants
n=93 Participants
|
|
Primary Indication for ICD Implant
Ischemic Cardiomyopathy
|
61 Participants
n=93 Participants
|
|
Primary Indication for ICD Implant
Non-ischemic Cardiomyopathy
|
50 Participants
n=93 Participants
|
|
Primary Indication for ICD Implant
Syncope
|
9 Participants
n=93 Participants
|
|
Primary Indication for ICD Implant
Familial Condition
|
2 Participants
n=93 Participants
|
|
Primary Indication for ICD Implant
Other
|
4 Participants
n=93 Participants
|
|
History of Smoking
Number of years smoking < 10
|
9 Participants
n=93 Participants
|
|
History of Smoking
Number of years smoking 10 - 20
|
8 Participants
n=93 Participants
|
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History of Smoking
Number of years smoking > 20
|
12 Participants
n=93 Participants
|
|
History of Smoking
No smoking or no response
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176 Participants
n=93 Participants
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PRIMARY outcome
Timeframe: from MRI scan visit to 1 month post-MRI scan visitPopulation: 177 subjects (86.3% of enrolled subjects) completed through the 1-month post-MRI scan visit and are included in the primary safety endpoint analysis
\*A complication is a serious adverse device effect (SADE) that requires an invasive intervention or leads to death. The primary endpoint analysis will be performed for each study phase separately.
Outcome measures
| Measure |
Thoracic MRI Scan With 1.5 Tesla MRI
n=177 Participants
Subjects will be enrolled at least 60 days post successful St. Jude Medical™ MR Conditional ICD System implant. Enrolled subjects will undergo an elective 1.5T MRI scan within 30 days post enrollment. Post MRI visit all subjects will be followed up at 1-Month post MRI visit.
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|---|---|
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Number of Participants With Freedom From MRI-scan Related Complications* Related to St. Jude Medical™ MR Conditional ICD System
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177 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: MRI scan visitPopulation: Subjects completing the MRI scan in its entirety
The average Specific Absorption Rate (SAR) during the MRI scan
Outcome measures
| Measure |
Thoracic MRI Scan With 1.5 Tesla MRI
n=180 Participants
Subjects will be enrolled at least 60 days post successful St. Jude Medical™ MR Conditional ICD System implant. Enrolled subjects will undergo an elective 1.5T MRI scan within 30 days post enrollment. Post MRI visit all subjects will be followed up at 1-Month post MRI visit.
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|---|---|
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The Average Specific Absorption Rate (SAR)
|
1.9 Watts/kg
Standard Deviation 0.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: from MRI scan visit to 1-month post MRI scan visitPopulation: Subjects who had high voltage lead implanted, underwent an MRI scan and had both pre MRI scan and 1 month post MRI scan sensing amplitudes available
This proportion was calculated as the number of subjects who had high voltage leads with capture threshold increases of ≤ 0.5V @ 0.5 ms from pre MRI scan testing to 1-month post MRI scan testing divided by total number of subjects who had high voltage lead implanted, underwent an MRI scan and had both pre-MRI scan and 1-month post MRI scan capture threshold measurements available.
Outcome measures
| Measure |
Thoracic MRI Scan With 1.5 Tesla MRI
n=172 Participants
Subjects will be enrolled at least 60 days post successful St. Jude Medical™ MR Conditional ICD System implant. Enrolled subjects will undergo an elective 1.5T MRI scan within 30 days post enrollment. Post MRI visit all subjects will be followed up at 1-Month post MRI visit.
|
|---|---|
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Number of Participants With Freedom From MRI-scan Related Complications* Related to St. Jude Medical™ MR Conditional ICD System
|
168 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: from pre MRI scan to 1-month post MRI scanPopulation: subjects who had high voltage lead implanted, underwent an MRI scan and had both pre MRI scan and 1 month post MRI scan sensing amplitudes available
This proportion was calculated as the number of subjects who had high voltage leads with sensing amplitude decrease of ≤ 50% from pre MRI scan testing to 1 month post MRI scan testing divided by the total number of subjects who had high voltage lead implanted, underwent an MRI scan and had both pre MRI scan and 1 month post MRI scan sensing amplitudes available.
Outcome measures
| Measure |
Thoracic MRI Scan With 1.5 Tesla MRI
n=174 Participants
Subjects will be enrolled at least 60 days post successful St. Jude Medical™ MR Conditional ICD System implant. Enrolled subjects will undergo an elective 1.5T MRI scan within 30 days post enrollment. Post MRI visit all subjects will be followed up at 1-Month post MRI visit.
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|---|---|
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Proportion of SJM High Voltage Lead Implanted With SJM MR Conditional ICD With Sensing Amplitude Decrease of ≤ 50% From Pre-MRI Scan Testing to 1 Month Post-MRI Scan Testing
|
173 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: MRI Scan VisitPopulation: The peak SAR was calculated for 56 subjects with available data
The peak Specific Absorption Rate (SAR) during the MRI scan
Outcome measures
| Measure |
Thoracic MRI Scan With 1.5 Tesla MRI
n=56 Participants
Subjects will be enrolled at least 60 days post successful St. Jude Medical™ MR Conditional ICD System implant. Enrolled subjects will undergo an elective 1.5T MRI scan within 30 days post enrollment. Post MRI visit all subjects will be followed up at 1-Month post MRI visit.
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|---|---|
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The Peak Specific Absorption Rate (SAR) During the MRI Scan
|
1.5 W/kg
Standard Deviation 0.3
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OTHER_PRE_SPECIFIED outcome
Timeframe: MRI VisitPopulation: The mean MRI visit duration in the MRI lab for 181 subjects completing the MRI scan visit
The mean MRI visit duration in the MRI lab
Outcome measures
| Measure |
Thoracic MRI Scan With 1.5 Tesla MRI
n=181 Participants
Subjects will be enrolled at least 60 days post successful St. Jude Medical™ MR Conditional ICD System implant. Enrolled subjects will undergo an elective 1.5T MRI scan within 30 days post enrollment. Post MRI visit all subjects will be followed up at 1-Month post MRI visit.
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|---|---|
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The Mean MRI Visit Duration in the MRI Lab
|
37.3 minutes
Standard Deviation 11.1
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OTHER_PRE_SPECIFIED outcome
Timeframe: MRI VisitPopulation: Subjects completing the MRI scan
Total MRI scan duration in MRI laboratory
Outcome measures
| Measure |
Thoracic MRI Scan With 1.5 Tesla MRI
n=180 Participants
Subjects will be enrolled at least 60 days post successful St. Jude Medical™ MR Conditional ICD System implant. Enrolled subjects will undergo an elective 1.5T MRI scan within 30 days post enrollment. Post MRI visit all subjects will be followed up at 1-Month post MRI visit.
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|---|---|
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Total MRI Scan Duration in MRI Laboratory
|
24.4 minutes
Standard Deviation 1.4
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Adverse Events
Thoracic MRI Scan With 1.5 Tesla MRI
Serious events: 1 serious events
Other events: 1 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Thoracic MRI Scan With 1.5 Tesla MRI
n=205 participants at risk
Subjects will be enrolled at least 60 days post successful St. Jude Medical™ MR Conditional ICD System implant. Enrolled subjects will undergo an elective 1.5T MRI scan within 30 days post enrollment. Post MRI visit all subjects will be followed up at 1-Month post MRI visit.
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|---|---|
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Respiratory, thoracic and mediastinal disorders
Breathlessness
|
0.49%
1/205 • Number of events 1 • Adverse events were collected from the time participants were enrolled, through the MRI scan Visit and the 1 month Post MRI Scan Visit follow-up, or the study completion (if subject withdrawn before the final follow-up).
* Adverse Device Effect (ADE)- An adverse event (AE) related to the use of a medical device. This definition includes AEs resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the medical device and any event resulting from the use error or from intentional misuse of the medical device. * Serious Adverse Device Effect - ADE that has resulted in any of the consequences characteristic of a Serious AE
|
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Cardiac disorders
Refractory cardiogenic shock, recurrent ventricular tachycardia, ventricular fibrillation
|
0.49%
1/205 • Number of events 1 • Adverse events were collected from the time participants were enrolled, through the MRI scan Visit and the 1 month Post MRI Scan Visit follow-up, or the study completion (if subject withdrawn before the final follow-up).
* Adverse Device Effect (ADE)- An adverse event (AE) related to the use of a medical device. This definition includes AEs resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the medical device and any event resulting from the use error or from intentional misuse of the medical device. * Serious Adverse Device Effect - ADE that has resulted in any of the consequences characteristic of a Serious AE
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.49%
1/205 • Number of events 1 • Adverse events were collected from the time participants were enrolled, through the MRI scan Visit and the 1 month Post MRI Scan Visit follow-up, or the study completion (if subject withdrawn before the final follow-up).
* Adverse Device Effect (ADE)- An adverse event (AE) related to the use of a medical device. This definition includes AEs resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the medical device and any event resulting from the use error or from intentional misuse of the medical device. * Serious Adverse Device Effect - ADE that has resulted in any of the consequences characteristic of a Serious AE
|
|
Respiratory, thoracic and mediastinal disorders
Serious Adverse Device Effect: Acute Pulmonary Edema
|
0.49%
1/205 • Number of events 1 • Adverse events were collected from the time participants were enrolled, through the MRI scan Visit and the 1 month Post MRI Scan Visit follow-up, or the study completion (if subject withdrawn before the final follow-up).
* Adverse Device Effect (ADE)- An adverse event (AE) related to the use of a medical device. This definition includes AEs resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the medical device and any event resulting from the use error or from intentional misuse of the medical device. * Serious Adverse Device Effect - ADE that has resulted in any of the consequences characteristic of a Serious AE
|
Other adverse events
| Measure |
Thoracic MRI Scan With 1.5 Tesla MRI
n=205 participants at risk
Subjects will be enrolled at least 60 days post successful St. Jude Medical™ MR Conditional ICD System implant. Enrolled subjects will undergo an elective 1.5T MRI scan within 30 days post enrollment. Post MRI visit all subjects will be followed up at 1-Month post MRI visit.
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|---|---|
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Product Issues
Loss of Capture
|
0.49%
1/205 • Number of events 1 • Adverse events were collected from the time participants were enrolled, through the MRI scan Visit and the 1 month Post MRI Scan Visit follow-up, or the study completion (if subject withdrawn before the final follow-up).
* Adverse Device Effect (ADE)- An adverse event (AE) related to the use of a medical device. This definition includes AEs resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the medical device and any event resulting from the use error or from intentional misuse of the medical device. * Serious Adverse Device Effect - ADE that has resulted in any of the consequences characteristic of a Serious AE
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place