A Post-market Clinical Evaluation of St. Jude Medical™ MR Conditional ICD System on Patients Undergoing Magnetic Resonance Imaging (ASIA MRI ICD)
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|ClinicalTrials.gov Identifier: NCT02877693|
Recruitment Status : Recruiting
First Posted : August 24, 2016
Last Update Posted : March 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|ICD Tachycardia||Radiation: Thoracic MRI Scan||Not Applicable|
This clinical investigation is a prospective, multicenter, 2-phase, single arm, Asian study.
- In the 1st phase patients will be enrolled within 60 days of implant with a St. Jude Medical™ MR Conditional ICD System approved for thoracic scan with 1.5 Tesla MRI scanning machines.
In the 2nd phase patients will be enrolled within 60 days of implant with a St. Jude Medical™ MR Conditional ICD System approved* for thoracic scan with 3.0 Tesla MRI scanning machines.
- NOTE: The 2nd phase of this study will start only after receiving appropriate regulatory approval for MRI labelling at 3.0T and phase 1 enrollment has completed
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||396 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Post-market Clinical Evaluation of St. Jude Medical™ MR Conditional ICD System on Patients Undergoing Magnetic Resonance Imaging|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||December 2020|
Thoracic MRI Scan
Subjects will be enrolled within 60 days of successful St. Jude Medical™ MR Conditional ICD System implant or within 60 days post most recent lead revision (if applicable) whichever is latter. Enrolled subjects will undergo an elective MRI scan from 60-90 days of implant or most recent lead revision (if applicable) whichever is latter. Post MRI visit all subjects will be followed up at 1-Month post MRI visit.
Radiation: Thoracic MRI Scan
is to demonstrate the MRI scan will not adversely affect the functionality of the ICD system. To do so, the ICD system will be exposed to MRI scan of thoracic region, where the radiofrequency (RF) component of the scan is maximized.
- Freedom from MRI-scan related complications* related to St. Jude Medical™ MR Conditional ICD System [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02877693
|Contact: Louise Yim||+852 2996 email@example.com|
|Contact: Sumit Anand||+91 11 firstname.lastname@example.org|
|Escorts Heart Institute and Research Centre||Recruiting|
|New Delhi, India|
|Contact: Kler Tarlochan|
|Principal Investigator: Kler Tarlochan|
|Study Director:||Grant Kim||St. Jude Medical, Inc.|