EMRI SureScan™ Clinical Study

This study has been completed.
Sponsor:
Information provided by:
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00433654
First received: February 2, 2007
Last updated: October 17, 2011
Last verified: July 2011

February 2, 2007
October 17, 2011
February 2007
November 2008   (final data collection date for primary outcome measure)
  • Magnetic Resonance Imaging (MRI)-Related Complications [ Time Frame: MRI scan to one-month post-MRI scan ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).
  • Ventricular Sensed Amplitude Success [ Time Frame: 9-12 week visit to 4-month visit ] [ Designated as safety issue: No ]
    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).
  • Assess safety of pacemaker system in MRI machine
  • Assess performance of pacemaker system in the top and bottom heart chambers following MRI scans
Complete list of historical versions of study NCT00433654 on ClinicalTrials.gov Archive Site
  • Subjects With System-related Complications [ Time Frame: Implant to 4 Months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Average atrial sensed amplitude.
  • Ventricular Sensed Amplitude [ Time Frame: 3 or 4 months post-implant ] [ Designated as safety issue: No ]
    Average ventricular sensed amplitude.
  • 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
Not Provided
Not Provided
 
EMRI SureScan™ Clinical Study
EnRhythm MRI™ SureScan™ Pacing System Clinical Investigation

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Bradycardia
  • Slow Heart Beat
  • Device: Implantable Pulse Generator (IPG) and Pacing Leads (wires)
    Pacer and leads
  • Other: Magnetic Resonance Imaging (MRI) scan
    One hour MRI scan on the head and lower back.
  • Active Comparator: MRI group
    The MRI group underwent a one-hour MRI scan at the 9-12 weeks post-implant follow-up.
    Interventions:
    • Device: Implantable Pulse Generator (IPG) and Pacing Leads (wires)
    • Other: Magnetic Resonance Imaging (MRI) scan
  • Control group
    The control group waited for one hour (no MRI) at the 9-12 weeks post-implant follow-up.
    Intervention: Device: Implantable Pulse Generator (IPG) and Pacing Leads (wires)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
484
August 2010
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject has, or is at risk of having, a heart beat that is too slow and his/her doctor has determined he/she needs a pacemaker.
  • Subject available for follow-up at study center for length of study.
  • Subject able and willing to undergo elective MRI scanning without sedation.

Exclusion Criteria:

  • Subject has, or is at risk of having, a heart beat that is too fast and his/her doctor has determined he/she needs an implantable cardioverter defibrillator (ICD).
  • Subject needs or will need another MRI-scan, other than those required by the study, during the required study follow-up period.
  • Pregnant women, or women of child bearing potential who are not on a reliable form of birth control.
  • Subject with exclusion criteria required by local law.
  • Subject who intends to participate in another clinical study during this clinical study.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Germany,   United States,   Austria,   Belgium,   Canada,   Czech Republic,   France,   United Kingdom,   Italy,   Netherlands,   Switzerland
 
NCT00433654
212
Yes
EMRI Clinical Research Specialist, Medtronic, Inc.
Medtronic Cardiac Rhythm Disease Management
Not Provided
Study Chair: EMRI SureScan Clinical Study Team Medtronic
Medtronic Cardiac Rhythm Disease Management
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP