Clinical Trial: EMRI SureScan™ Clinical Study
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: EnRhythm MRI™ SureScan™ Pacing System Clinical Investigation
Brief Summary: 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).
Detailed Summary: This study is a prospective, multi-center global study.
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Current Primary Outcome:
- Magnetic Resonance Imaging (MRI)-Related Complications [ Time Frame: MRI scan to one-month post-MRI scan ]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.
- Atrial Pacing Capture Threshold Success [ Time Frame: 9-12 week visit to 4-month visit ]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.
- Ventricular Pacing Capture Threshold Success [ Time Frame: 9-12 week visit to 4-month visit ]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.
- Atrial Sensed Amplitude Success [ Time Frame: 9-12 week visit to 4-month visit ]Subjects' atrial sensed amplitude (the
Original Primary Outcome:
- Assess safety of pacemaker system in MRI machine
- Assess performance of pacemaker system in the top and bottom heart chambers following MRI scans
Current Secondary Outcome:
- Subjects With System-related Complications [ Time Frame: Implant to 4 Months ]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.
- System Related Adverse Device Effects Due to Labeling Instructions [ Time Frame: Implant through 18 months post-implant ]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.
- Occurrence of Arrhythmias [ Time Frame: During the MRI scan ]Number of participants with sustained ventricular arrhythmias or asystole episodes that occurred during the MRI scan that were considered attributable to the MRI scan
- Atrial Lead Impedance Change [ Time Frame: 9-12 week visit and 4-month visit ]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.
- Ventricular Lead Impedance Change [ Time Frame: 9-12 week visit and 4-month visit ]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.
- Atrial Lead Handling Rating [ Time Frame: During implant ]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.
- Ventricular Lead Handling Rating [ Time Frame: During implant ]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.
- Atrial Pacing Capture Threshold [ Time Frame: 3 or 4 months post-implant ]Average atrial pacing capture threshold. Pacing capture threshold is the energy needed to pace the heart.
- Ventricular Pacing Capture Threshold [ Time Frame: 3 or 4 months post-implant ]Average ventricular pacing capture threshold. Pacing capture threshold is the energy needed to pace the heart.
- Atrial Sensed Amplitude [ Time Frame: 3 or 4 months post-implant ]Average atrial sensed amplitude.
- Ventricular Sensed Amplitude [ Time Frame: 3 or 4 months post-implant ]Average ventricular sensed amplitude.
Original Secondary Outcome:
- Summarize number of abnormal heart beats during MRI scans
- Summarize all harmful events (study related and non-study related) during the study
- Compare pacemaker lead (wire) performance to currently available leads
Information By: Medtronic Cardiac Rhythm and Heart Failure
Dates:
Date Received: February 2, 2007
Date Started: February 2007
Date Completion:
Last Updated: October 17, 2011
Last Verified: July 2011
