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Trial record 1 of 3 for:    Advisa MRI
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Advisa MRI Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01110915
Recruitment Status : Completed
First Posted : April 27, 2010
Results First Posted : April 4, 2013
Last Update Posted : April 30, 2013
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Tracking Information
First Submitted Date  ICMJE April 23, 2010
First Posted Date  ICMJE April 27, 2010
Results First Submitted Date  ICMJE February 20, 2013
Results First Posted Date  ICMJE April 4, 2013
Last Update Posted Date April 30, 2013
Study Start Date  ICMJE June 2010
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2013)
  • Magnetic Resonance Imaging (MRI)-Related Complications [ Time Frame: MRI scan to one-month post-MRI scan ]
    For each subject in this objective, the endpoint was the occurrence of an MRI-related complication within 30 days post-MRI. An independent Adverse Event Advisory Committee (AEAC) determined whether each adverse event was a complication and whether it was MRI-related.
  • Atrial Pacing Capture Threshold Success [ Time Frame: Pre-MRI/waiting period to one month post-MRI/waiting period ]
    Subjects' atrial pacing capture threshold was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was when a subject experienced an increase less than or equal to 0.5V (volts) between the two visits.
  • Ventricular Pacing Capture Threshold Success [ Time Frame: Pre-MRI /waiting period to 1-month post-MRI/waiting period ]
    Subjects' ventricular pacing capture threshold was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was when a subject experienced an increase less than or equal to 0.5V (volts) between the two visits.
Original Primary Outcome Measures  ICMJE
 (submitted: April 23, 2010)
  • MRI-related complication-free rate [ Time Frame: 1 Month post MRI ]
  • Proportion of subjects who experience an increase less than or equal to 0.75V in atrial voltage thresholds [ Time Frame: Pre-MRI/waiting period to one month post-MRI/waiting period ]
  • Proportion of subjects who experience an increase less than or equal to 0.75V in ventricular voltage thresholds [ Time Frame: Pre-MRI /waiting period to 1-month post-MRI/waiting period ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2013)
  • Atrial Sensed Amplitude Success [ Time Frame: Pre-MRI /waiting period to 1-month post-MRI/waiting period ]
    Subjects' atrial sensed amplitude was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was defined as a 50% or less decrease in atrial sensed amplitude between the two visits.
  • Ventricular Sensed Amplitude Success [ Time Frame: Pre-MRI /waiting period to 1-month post-MRI/waiting period ]
    Subjects' ventricular sensed amplitude was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was defined as a 50% or less decrease in ventricular sensed amplitude between the two visits.
  • Occurrence of Sustained Ventricular Arrhythmias and Asystole During MRI Scans. [ Time Frame: During MRI scans ]
    The endpoint was the occurrence of sustained ventricular arrhythmias and asystole during MRI scans and attributable to the MR scan. Sustained ventricular arrhythmias or asystole episodes that occurred during the MRI scan was considered attributable to the MR scan if so adjudicated by the AEAC.
  • System-related Complications [ Time Frame: Implant to four months post implant ]
    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 the AEAC. The AEAC determined whether each adverse event was a complication (requiring invasive intervention), and whether the event was related to the system.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2010)
  • Proportion of subjects who experience a decrease less than or equal to 50% in atrial sensing amplitude [ Time Frame: Pre-MRI /waiting period to 1-month post-MRI/waiting period ]
  • Percentage of subjects free of sustained ventricular arrhythmias and asystole [ Time Frame: During MRI scans ]
  • Pacing system-related complication-free rate [ Time Frame: Implant to four months post implant ]
  • Proportion of subjects who experience a decrease less than or equal to 50% in ventricular sensing amplitude [ Time Frame: Pre-MRI /waiting period to 1-month post-MRI/waiting period ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Advisa MRI Clinical Study
Official Title  ICMJE Advisa MRI™ System Clinical Investigation
Brief Summary The purpose of the Advisa MRI System clinical study is to confirm safety and effectiveness in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans up to 2W/kg Specific Absorption Rate (SAR) without positioning restrictions (MRI scans may occur anywhere on the body including the chest).
Detailed Description

The Advisa MRI IPG is a dual chamber, multi-programmable IPG. The IPG is indicated to restore heart rates, improve cardiac output, prevent symptoms, or protect against arrhythmias related to cardiac impulse formation or conduction disorders. The IPG is indicated for use in patients who may benefit from rate-responsive pacing to support cardiac output during varying levels of activity and has been modified for use during an MRI exam.

Subjects will have required follow-up visits after implant, at 2 months, 9-12 weeks, 3 months, 4 months, 6 months and every 6 months thereafter until the study ends. The MR scans will occur at the 9-12 weeks visit.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Magnetic Resonance Imaging
  • Cardiac Pacemaker, Artificial
Intervention  ICMJE
  • Device: Medtronic Advisa MRI Implantable Pulse Generator (IPG)
    Advisa MRI IPG is a dual chamber, multi-programmable IPG indicated to restore heart rates, improve cardiac output, prevent symptoms, or protect against arrhythmias related to cardiac impulse formation or conduction disorders. The IPG is indicated for use in patients who may benefit from rate-responsive pacing to support cardiac output during varying levels of activity and has been modified for use during an MRI exam.
    Other Names:
    • Model A2DR01
    • Model A3DR01
  • Device: Medtronic CapSureFix MRI™ active fixation MRI lead
    The Medtronic CapSureFix MRI™ active fixation MRI lead is a transvenous, bipolar, silicone, steroid eluting and active fixation pacing lead. It is based on the commercially available Medtronic Model 5076 lead and has been modified for use in the MRI environment. The MRI lead is used for both atrial and ventricular applications.
    Other Name: Model 5086 MRI lead
Study Arms  ICMJE
  • Experimental: MRI group
    Subjects randomized to the MRI group will undergo a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
    Interventions:
    • Device: Medtronic Advisa MRI Implantable Pulse Generator (IPG)
    • Device: Medtronic CapSureFix MRI™ active fixation MRI lead
  • Active Comparator: Control group
    Subjects randomized to the Control group will wait for one hour without having any MRI scan at 9-12 weeks post-implant.
    Interventions:
    • Device: Medtronic Advisa MRI Implantable Pulse Generator (IPG)
    • Device: Medtronic CapSureFix MRI™ active fixation MRI lead
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 20, 2013)
269
Original Estimated Enrollment  ICMJE
 (submitted: April 23, 2010)
270
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects who have a Class I or II indication for implantation of a dual chamber pacemaker according to the American College of Cardiology (ACC)/American Heart Association (AHA)/Heart Rhythm Society (HRS) guidelines
  • Subjects who are able to undergo a pectoral implant
  • Subjects who are able and willing to undergo elective magnetic resonance (MR) scanning without sedation
  • Subjects who are geographically stable and available for follow-up at the study center for the length of the study

Exclusion Criteria:

  • Subjects with a mechanical tricuspid heart valve
  • Subjects with a history of significant tricuspid valvular disease
  • Subjects for whom a single dose of 1.0 milligram (mg) dexamethasone acetate may be contraindicated
  • Subjects who require a legally authorized representative to obtain consent
  • Subjects who have a previously implanted pacemaker or implantable cardioverter defibrillator (ICD) (abandoned pacemaker and/or defibrillator leads are not permitted; however subjects with complete system explants are not excluded)
  • Subjects who are immediate candidates for an ICD
  • Subjects who require an indicated MR scan, other than those specifically described in the study, before the 4 months follow-up
  • Subjects with previously implanted active medical devices
  • Subjects with a non-MRI compatible device (such as ICDs or neurostimulators) or material implant (e.g. non-MRI compatible sternal wires, neurostimulators, biostimulators, metals or alloys)
  • Subjects with medical conditions that preclude the testing required by the protocol or limit study participation
  • Subjects who are enrolled or intend to participate in another clinical trial (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during this clinical study
  • Pregnant women, or women of child bearing potential and who are not on a reliable form of birth control
  • Subjects with exclusion criteria required by local law (e.g. age, breastfeeding)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Canada,   France,   Germany,   Hungary,   Israel,   Italy,   Netherlands,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01110915
Other Study ID Numbers  ICMJE AdvisaMRI
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medtronic Cardiac Rhythm and Heart Failure
Study Sponsor  ICMJE Medtronic Cardiac Rhythm and Heart Failure
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Advisa MRI Trial Leader Medtronic
PRS Account Medtronic Cardiac Rhythm and Heart Failure
Verification Date April 2013

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