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To assess the clinical performance of the St. Jude Medical™ MR Conditional ICD System in patients undergoing an elective thoracic MRI scan.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thoracic MRI Scan with 1.5 Tesla MRI | Experimental | 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 | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thoracic MRI Scan | Radiation | The ICD system will be exposed to MRI scan of thoracic region, where the radiofrequency (RF) component of the scan is maximized. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | from MRI scan visit to 1 month post-MRI scan visit |
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| Measure | Description | Time Frame |
|---|---|---|
| The Average Specific Absorption Rate (SAR) | The average Specific Absorption Rate (SAR) during the MRI scan | MRI scan visit |
| Number of Participants With Freedom From MRI-scan Related Complications* Related to St. Jude Medical™ MR Conditional ICD System |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grant Kim | St. Jude Medical, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medanta-The Medicity | Gurgaon | Haryana | 122001 | India | ||
| Post Graduate Institute of Medical Education & Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Tarlochan Singh Kler, Praveen Chandra, Chandrakant Chavan, Rajesh Vijayvergiya, Subhash Chandra, Anoop Gupta, Sridevi Chennapragada, Joung Bo Young, Mona Bhatia, Choi Eue Keun, Vanita Arora, Tom Devasia, Upendra Kaul, Sumit Anand, Kartikeya Bhargava. Initial experience of thoracic Magnetic Resonance Imaging (MRI) scanning in Asian patients implanted the Ellipse MR Conditional ICD System - The ASIA MRI ICD Study. APHRS 2017; Abstract no. 40528. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 4, 2017 |
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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.
| from MRI scan visit to 1-month post MRI scan visit |
| 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. | from pre MRI scan to 1-month post MRI scan |
| The Peak Specific Absorption Rate (SAR) During the MRI Scan | The peak Specific Absorption Rate (SAR) during the MRI scan | MRI Scan Visit |
| The Mean MRI Visit Duration in the MRI Lab | The mean MRI visit duration in the MRI lab | MRI Visit |
| Total MRI Scan Duration in MRI Laboratory | Total MRI scan duration in MRI laboratory | MRI Visit |
| Chandigarh |
| 160012 |
| India |
| BLK Super Speciality Hospital | Delhi | 110005 | India |
| Max Super Specialty Hospital | Delhi | 110017 | India |
| Pushpawati Singhania Research Institute | Delhi | 110017 | India |
| Apollo Gleneagles Hospital | Delhi | India |
| Batra Hospital & Medical Research Centre | Delhi | India |
| Fortis Flt. Lt. Rajan Dhall Hospital | Delhi | India |
| National Heart Institute | Delhi | India |
| Medanta Medicity Hospital | Gurgaon | 122001 | India |
| Care Hospital | Hyderabad | 500034 | India |
| Asian Heart Institute | Mumbai | 400051 | India |
| Escorts Heart Institute and Research Centre | New Delhi | India |
| Ruby Hall Clinic | Pune | 411001 | India |
| Hospital Serdang | Kajang | Malaysia |
| Dankook University Hospital | Cheonan | South Korea |
| Cha Bundang Medical Center | Seongnam-si | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Seoul St. Mary Hospital | Seoul | South Korea |
| Severance Hospital | Seoul | South Korea |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
|
The baseline analysis population consisted of study participants that provided and signed acknowledgement of informed consent and were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Cardiovascular History | Count of Participants | Participants |
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| Primary Indication for ICD Implant | Count of Participants | Participants |
| |||||||||||||||||||||||
| History of Smoking | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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 | Posted | Count of Participants | Participants | from MRI scan visit to 1 month post-MRI scan visit |
|
|
| ||||||||||||||||||||||||||
| Other Pre-specified | The Average Specific Absorption Rate (SAR) | The average Specific Absorption Rate (SAR) during the MRI scan | Subjects completing the MRI scan in its entirety | Posted | Mean | Standard Deviation | Watts/kg | MRI scan visit |
|
| ||||||||||||||||||||||||||
| 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. | 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 | Posted | Count of Participants | Participants | from MRI scan visit to 1-month post MRI scan visit |
|
| |||||||||||||||||||||||||||
| 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. | 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 | Posted | Count of Participants | Participants | from pre MRI scan to 1-month post MRI scan |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | The Peak Specific Absorption Rate (SAR) During the MRI Scan | The peak Specific Absorption Rate (SAR) during the MRI scan | The peak SAR was calculated for 56 subjects with available data | Posted | Mean | Standard Deviation | W/kg | MRI Scan Visit |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | The Mean MRI Visit Duration in the MRI Lab | The mean MRI visit duration in the MRI lab | The mean MRI visit duration in the MRI lab for 181 subjects completing the MRI scan visit | Posted | Mean | Standard Deviation | minutes | MRI Visit |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Total MRI Scan Duration in MRI Laboratory | Total MRI scan duration in MRI laboratory | Subjects completing the MRI scan | Posted | Mean | Standard Deviation | minutes | MRI Visit |
|
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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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 2 | 205 | 1 | 205 | 1 | 205 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breathlessness | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Refractory cardiogenic shock, recurrent ventricular tachycardia, ventricular fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Ventricular arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Serious Adverse Device Effect: Acute Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | *Event was conservatively classified as SADE due to unknown relationship to the device per the investigator's assessment. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Loss of Capture | Product Issues | Systematic Assessment | Device loss of capture |
|
The 3T MRI part of the study was not completed as the study was terminated upon completion of the 1.5T MRI part of the study
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grant Kim, Director Clinical Programs | Abbott | 818-493-3147 | grant.kim1@abbott.com |
| Feb 28, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| India |
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| No Cardiomyopathy |
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| Ischemic Cardiomyopathy |
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| Non-ischemic Cardiomyopathy |
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| Syncope |
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| Familial Condition |
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| Other |
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| Number of years smoking > 20 |
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| No smoking or no response |
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