The purpose of this clinical study is to confirm safety and efficacy in the clinical magnetic resonance imaging (MRI) environment of the investigational EnRhythm MRI™ SureScan™ Pacing System (used in support of Revo MRI™ SureScan Pacing System launch).
This study is a prospective, multi-center global study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
484
Pacer and leads
One hour MRI scan on the head and lower back.
Magnetic Resonance Imaging (MRI)-Related Complications
Subjects with a complication related to the MRI scan. All adverse events in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee. The committee determined whether each adverse event was a complication (requiring invasive intervention), and whether the event was related to the MRI scan.
Time frame: MRI scan to one-month post-MRI scan
Atrial Pacing Capture Threshold Success
Subjects' atrial pacing capture threshold (the energy sent from the pacemaker needed to make the heart's atrium beat) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their pacing capture threshold did not increase by 1.0 volt (V) or more.
Time frame: 9-12 week visit to 4-month visit
Ventricular Pacing Capture Threshold Success
Subjects' ventricular pacing capture threshold (the energy sent from the pacemaker needed to make the heart's ventricle beat) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their pacing capture threshold did not increase by 1.0 volt (V) or more.
Time frame: 9-12 week visit to 4-month visit
Atrial Sensed Amplitude Success
Subjects' atrial sensed amplitude (the minimum energy produced by the heart's atrium that the pacemaker can sense) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their sensed amplitude did not decrease by more than 50% and remained above 1.5 millivolts (mV).
Time frame: 9-12 week visit to 4-month visit
Ventricular Sensed Amplitude Success
Subjects' ventricular sensed amplitude (the minimum energy produced by the heart's ventricle that the pacemaker can sense) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their sensed amplitude did not decrease by more than 50% and remained above 5.0 millivolts (mV).
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Unnamed facility
Redwood City, California, United States
Unnamed facility
Salinas, California, United States
Unnamed facility
Orlando, Florida, United States
Unnamed facility
Peachtree City, Georgia, United States
Unnamed facility
Des Moines, Iowa, United States
Unnamed facility
Minneapolis, Minnesota, United States
Unnamed facility
Kansas City, Missouri, United States
Unnamed facility
St Louis, Missouri, United States
Unnamed facility
Mineola, New York, United States
Unnamed facility
Cincinnati, Ohio, United States
...and 35 more locations
Time frame: 9-12 week visit to 4-month visit
Subjects With System-related Complications
Subjects with a complication related to the implanted system, which consisted of the pacemaker, leads to the right chambers of the heart (atrium and ventricle), pacemaker software, and programmer. All adverse events in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee. The committee determined whether each adverse event was a complication (requiring invasive intervention), and whether the event was related to the system.
Time frame: Implant to 4 Months
System Related Adverse Device Effects Due to Labeling Instructions
Number of participants with adverse device effects (ADEs) that resulted from insufficiencies or inadequacies in the instructions for use or deployment of the device, or from user error. ADE's were investigator-reported.
Time frame: Implant through 18 months post-implant
Occurrence of Arrhythmias
Number of participants with sustained ventricular arrhythmias or asystole episodes that occurred during the MRI scan that were considered attributable to the MRI scan
Time frame: During the MRI scan
Atrial Lead Impedance Change
Subjects' atrial lead impedance (a measure of electrical resistance) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Both measurements were conducted by the pacemaker. The difference between the two is reported.
Time frame: 9-12 week visit and 4-month visit
Ventricular Lead Impedance Change
Subjects' ventricular lead impedance (a measure of electrical resistance) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Both measurements were conducted by the pacemaker. The difference between the two is reported.
Time frame: 9-12 week visit and 4-month visit
Atrial Lead Handling Rating
Physicians' rated atrial lead handling during the implant on a scale of -3 to +3 where: -3 = well below expectations; -2 = moderately below expectations; -1 = slightly below expectations; 0 = met expectations; +1 = slightly above expectations; +2 = moderately above expectations; and +3 = well above expectations.
Time frame: During implant
Ventricular Lead Handling Rating
Physicians' rated ventricular lead handling during the implant on a scale of -3 to +3 where: -3 = well below expectations; -2 = moderately below expectations; -1 = slightly below expectations; 0 = met expectations; +1 = slightly above expectations; +2 = moderately above expectations; and +3 = well above expectations.
Time frame: During implant
Atrial Pacing Capture Threshold
Average atrial pacing capture threshold. Pacing capture threshold is the energy needed to pace the heart.
Time frame: 3 or 4 months post-implant
Ventricular Pacing Capture Threshold
Average ventricular pacing capture threshold. Pacing capture threshold is the energy needed to pace the heart.
Time frame: 3 or 4 months post-implant
Atrial Sensed Amplitude
Average atrial sensed amplitude.
Time frame: 3 or 4 months post-implant
Ventricular Sensed Amplitude
Average ventricular sensed amplitude.
Time frame: 3 or 4 months post-implant