The objective of the SAMURAI Clinical Study is to collect data to confirm the safety, performance and effectiveness of the ImageReady System for use in the Magnetic Resonance Imaging (MRI) environment when used in accordance with the Conditions of Use included in the Boston Scientific MRI Technical Guide
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
363
The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment
Pacemaker and lead(s) implant
Proportion of Participants Without MR Scan-related Complications
The primary safety endpoint for SAMURAI will be assessed for all subjects randomized to the MRI Group who undergo any portion of the MRI scan sequences. Safety will be confirmed by evaluating the MRI scan-related Complication-free rate (CFR) between the MR Scan and the MRI Visit + 1 Month Visit.
Time frame: MRI Visit + 1 Month
Success Rate for Threshold Measurement at 1 Month Post-MRI Scan or Control Group Visit
The MRI scan can result in damage to cardiac tissue surrounding lead electrodes due to RF field-induced heating, which in turn may cause elevated pacing thresholds. Primary Effectiveness Endpoint 1 will evaluate any chronic effects from lead heating that will be seen through increased pacing threshold at the MRI Visit + 1 Month follow-up. Subjects with an increase in pacing thresholds s 0.5V (at 0.5 ms) from pre-MR Scan/Control Group visit to MRI/Control visit + 1 Month follow-up were considered a success. A success rate was calculated for both the MRI and the Control Groups.
Time frame: MRI + 1 Month Visit
Success Rate for Sensed Amplitude Measurement at 1 Month Post-MRI Scan or Control Group Visit
The MRI scan can result in damage to cardiac tissue surrounding lead electrodes due to Radiofrequency (RF) field-induced heating. Primary Effectiveness Endpoint 2 will evaluate any chronic effects from lead heating that will be seen through decreased sensed amplitude at the MRI Visit + 1 Month follow-up. Data were analyzed separately by chamber, Right Atrium (RA) and Right Ventricle (RV), for this endpoint.
Time frame: MRI + 1 Month Visit
Proportion of Participants Without ImageReady System-related Complications
Overall safety of the ImageReady System will be confirmed by evaluating system-related complications that occur from system implant through 3 months post implant for all subjects who underwent an implant procedure and and reached 91 days of follow-up.
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Banner Heart Hospital
Mesa, Arizona, United States
USC Medical Center
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Orlando Regional Medical Center
Orlando, Florida, United States
University Community Hospital
Trinity, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
University of Chicago Hospital
Chicago, Illinois, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
...and 31 more locations
Time frame: 3 months post implant