Advisa MRI Clinical Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01110915
First received: April 23, 2010
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

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).


Condition Intervention
Magnetic Resonance Imaging
Cardiac Pacemaker, Artificial
Device: Medtronic Advisa MRI Implantable Pulse Generator (IPG)
Device: Medtronic CapSureFix MRI™ active fixation MRI lead

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Advisa MRI™ System Clinical Investigation

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Magnetic Resonance Imaging (MRI)-Related Complications [ Time Frame: MRI scan to one-month post-MRI scan ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Atrial Sensed Amplitude Success [ Time Frame: Pre-MRI /waiting period to 1-month post-MRI/waiting period ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ 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 the AEAC. The AEAC determined whether each adverse event was a complication (requiring invasive intervention), and whether the event was related to the system.


Enrollment: 269
Study Start Date: June 2010
Study Completion Date: March 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01110915

  Show 37 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Study Chair: Advisa MRI Trial Leader Medtronic
  More Information

Publications:
Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT01110915     History of Changes
Other Study ID Numbers: AdvisaMRI
Study First Received: April 23, 2010
Results First Received: February 20, 2013
Last Updated: April 23, 2013
Health Authority: Austria: Agency for Health and Food Safety
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: German Institute of Medical Documentation and Information
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Italy: Ministry of Health
Netherlands: Ministry of Health, Welfare and Sport
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Canada: Ethics Review Committee
Australia: Human Research Ethics Committee

ClinicalTrials.gov processed this record on July 23, 2014