ICD, Tachycardia
Conditions
Keywords
ICD, Thoracic MRI Scan, tachycardia
Brief summary
To assess the clinical performance of the St. Jude Medical™ MR Conditional ICD System in patients undergoing an elective thoracic MRI scan.
Detailed description
This clinical investigation is a prospective, multicenter, Asian study. The study was designed with two (2) parts, however only the 1st part was completed. For the 1st part, patients were enrolled with a SJM MR Conditional ICD System approved for thoracic scan with 1.5 Tesla MRI scanning machines. The 2nd part-meant to enroll patients for thoracic scans with 3 Tesla MRI scanning machines-was not completed.
Interventions
RADIATIONThoracic MRI Scan
The ICD system will be exposed to MRI scan of thoracic region, where the radiofrequency (RF) component of the scan is maximized.
Sponsors
Abbott Medical Devices
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is pectorally implanted with St. Jude Medical™ MR Conditional ICD System for at least 60 days 2. Subject is willing to undergo an elective MRI scan without sedation NOTE: Antianxiety agents (e.g. minor tranquilizers, etc.) may be used as long as the patient can communicate with site personnel during the MRI scan 3. Subject's ventricular bipolar capture threshold is stable \< 2.5V @ 0.5ms 4. Subject's ventricular sensing is measurable (patient has underlying rhythm \> 30bpm) and the sensing amplitude is stable \> 4mV 5. Subject is able to provide informed consent for study participation (legal guardian or legally authorized representative is NOT acceptable) 6. Subject is willing and able to comply with the prescribed follow-up tests and procedures 7. Subject is not contraindicated for an MRI scan (per the MRI Screening Form)
Exclusion criteria
1. Subject is pacemaker dependent 2. Subject has a non SJM MRI compatible endocardial lead implanted or capped 3. Subject has another existing active implanted medical device, e.g., neurostimulator, infusion pump, etc. that has MR labeling that will not allow the MRI scans per this protocol to be completed. 4. Subject has a high voltage lead revision incidence \< 60 days of the enrollment visit 5. Subject has other non-MRI compatible device or material implanted NOTE: MRI compatible knee replacements, hip replacements, stents, etc. may be included as long as the labeling of these devices allow MRI scans conducted per this protocol NOTE: MRI compatible mechanical, prosthetic, and bioprosthetic heart valves may be included as long as the labeling of these devices allow for MRI scans conducted per this protocol NOTE: Non-removable dental implants may be included 6. Subject has a lead extender, adaptor, or capped/abandoned lead 7. Subject is enrolled or intend to participate in a clinical drug and/or device study (investigational device, investigational drug, new indication for a device or drug or additional testing beyond standard of care procedures), which could confound the results of this trial as determined by SJM. 8. Subject is pregnant or planning to become pregnant during the duration of the subject's participation in the study 9. Subject has a life expectancy of less than 12 months due to any condition 10. Subject has
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Freedom From MRI-scan Related Complications* Related to St. Jude Medical™ MR Conditional ICD System | from MRI scan visit to 1 month post-MRI scan visit | \*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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Freedom From MRI-scan Related Complications* Related to St. Jude Medical™ MR Conditional ICD System | from MRI scan visit to 1-month post MRI scan visit | 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. |
| 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 | from pre MRI scan to 1-month post MRI scan | 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. |
| The Average Specific Absorption Rate (SAR) | MRI scan visit | The average Specific Absorption Rate (SAR) during the MRI scan |
| The Mean MRI Visit Duration in the MRI Lab | MRI Visit | The mean MRI visit duration in the MRI lab |
| Total MRI Scan Duration in MRI Laboratory | MRI Visit | Total MRI scan duration in MRI laboratory |
| The Peak Specific Absorption Rate (SAR) During the MRI Scan | MRI Scan Visit | The peak Specific Absorption Rate (SAR) during the MRI scan |
Countries
India, Malaysia, South Korea
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 205 |
| Total | 205 |
Baseline characteristics
| Characteristic | Thoracic MRI Scan With 1.5 Tesla MRI |
|---|---|
| Age, Continuous | 61.2 years STANDARD_DEVIATION 13.1 |
| Cardiovascular History Ischemic Cardiomyopathy | 93 Participants |
| Cardiovascular History No Cardiomyopathy | 37 Participants |
| Cardiovascular History Non-ischemic Cardiomyopathy | 75 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 178 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 21 Participants |
| History of Smoking No smoking or no response | 176 Participants |
| History of Smoking Number of years smoking < 10 | 9 Participants |
| History of Smoking Number of years smoking 10 - 20 | 8 Participants |
| History of Smoking Number of years smoking > 20 | 12 Participants |
| Primary Indication for ICD Implant Cardiac Arrest | 22 Participants |
| Primary Indication for ICD Implant Familial Condition | 2 Participants |
| Primary Indication for ICD Implant Ischemic Cardiomyopathy | 61 Participants |
| Primary Indication for ICD Implant Non-ischemic Cardiomyopathy | 50 Participants |
| Primary Indication for ICD Implant Other | 4 Participants |
| Primary Indication for ICD Implant Syncope | 9 Participants |
| Primary Indication for ICD Implant Ventricular Tachycardia | 57 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 201 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment India | 181 participants |
| Region of Enrollment Malaysia | 4 participants |
| Region of Enrollment South Korea | 20 participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 173 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 205 |
| other Total, other adverse events | 1 / 205 |
| serious Total, serious adverse events | 1 / 205 |
Outcome results
Primary
Number of Participants With Freedom From MRI-scan Related Complications* Related to St. Jude Medical™ MR Conditional ICD System
\*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.
Time frame: from MRI scan visit to 1 month post-MRI scan visit
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Thoracic MRI Scan With 1.5 Tesla MRI | Number of Participants With Freedom From MRI-scan Related Complications* Related to St. Jude Medical™ MR Conditional ICD System | 177 Participants |
Other Pre-specified
Number of Participants With Freedom From MRI-scan Related Complications* Related to St. Jude Medical™ MR Conditional ICD System
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.
Time frame: from MRI scan visit to 1-month post MRI scan visit
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Thoracic MRI Scan With 1.5 Tesla MRI | Number of Participants With Freedom From MRI-scan Related Complications* Related to St. Jude Medical™ MR Conditional ICD System | 168 Participants |
Other Pre-specified
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
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.
Time frame: from pre MRI scan to 1-month post MRI scan
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Thoracic MRI Scan With 1.5 Tesla MRI | 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
The Average Specific Absorption Rate (SAR)
The average Specific Absorption Rate (SAR) during the MRI scan
Time frame: MRI scan visit
Population: Subjects completing the MRI scan in its entirety
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thoracic MRI Scan With 1.5 Tesla MRI | The Average Specific Absorption Rate (SAR) | 1.9 Watts/kg | Standard Deviation 0.2 |
Other Pre-specified
The Mean MRI Visit Duration in the MRI Lab
The mean MRI visit duration in the MRI lab
Time frame: MRI Visit
Population: The mean MRI visit duration in the MRI lab for 181 subjects completing the MRI scan visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thoracic MRI Scan With 1.5 Tesla MRI | The Mean MRI Visit Duration in the MRI Lab | 37.3 minutes | Standard Deviation 11.1 |
Other Pre-specified
The Peak Specific Absorption Rate (SAR) During the MRI Scan
The peak Specific Absorption Rate (SAR) during the MRI scan
Time frame: MRI Scan Visit
Population: The peak SAR was calculated for 56 subjects with available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thoracic MRI Scan With 1.5 Tesla MRI | The Peak Specific Absorption Rate (SAR) During the MRI Scan | 1.5 W/kg | Standard Deviation 0.3 |
Other Pre-specified
Total MRI Scan Duration in MRI Laboratory
Total MRI scan duration in MRI laboratory
Time frame: MRI Visit
Population: Subjects completing the MRI scan
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thoracic MRI Scan With 1.5 Tesla MRI | Total MRI Scan Duration in MRI Laboratory | 24.4 minutes | Standard Deviation 1.4 |