ImageReady(TM) MR Conditional Pacing System Clinical Study (SAMURAI)
|Bradycardia Sinus Node Dysfunction||Radiation: MRI Device: ImageReady System implant|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||ImageReady(TM) MR Conditional Pacing System Clinical Study|
- Proportion of Participants Without MR Scan-related Complications [ Time Frame: MRI Visit + 1 Month ]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.
- Success Rate for Threshold Measurement at 1 Month Post-MRI Scan or Control Group Visit [ Time Frame: MRI + 1 Month 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.
- Success Rate for Sensed Amplitude Measurement at 1 Month Post-MRI Scan or Control Group Visit [ Time Frame: MRI + 1 Month 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.
- Proportion of Participants Without ImageReady System-related Complications [ Time Frame: 3 months post implant ]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.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||February 2019|
|Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Experimental: MRI Group
Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.
The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment
Other Name: MR ScanDevice: ImageReady System implant
Pacemaker and lead(s) implant
Experimental: Control Group
Those subjects randomized to the Control Group will not undergo s study-specific MRI scan. All follow-up time requirements are the same for the two groups.
Device: ImageReady System implant
Pacemaker and lead(s) implant
Please refer to this study by its ClinicalTrials.gov identifier: NCT01781078
Show 41 Study Locations
|Principal Investigator:||Ronald Berger, MD, PhD||Johns Hopkins Hospital, Carnegie 530, 600 N. Wolfe St, Baltimore, MD 21287|