Advisa MRI Clinical Study

Advisa MRI™ System Clinical Investigation

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).

Study Overview

• Status: Completed
• Conditions: Magnetic Resonance Imaging; Cardiac Pacemaker, Artificial
• Intervention / Treatment: Device: Medtronic Advisa MRI Implantable Pulse Generator (IPG); Device: Medtronic CapSureFix MRI™ active fixation 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.

• Study Type: Interventional
• Enrollment (Actual): 269
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia
      • St. George Hospital
  • Queensland
    • Chermside, Queensland, Australia
      • The Prince Charles Hospital
  • South Australia
    • Adelaide, South Australia, Australia
      • Adelaide Cardiology
  • Victoria
    • Richmond, Victoria, Australia
      • Epworth
• Austria
  • Sankt Pölten, Austria
    • Landesklinikum St. Pölten
• Belgium
  • Gilly, Belgium
    • Hôpital Saint-Joseph
• Canada
  • Quebec, Canada, G1V 4G5
    • Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
  • Quebec
    • Montreal, Quebec, Canada, H1T 1C8
      • Montreal Heart Institute
• France
  • Montpellier, France
    • CHRU Hôpital Arnaud de Villeneuve
  • Rouen Cedex, France
    • CHU Hôpiteaux de Rouen
  • Saint Etienne, France
    • Centre Hospitalier Universitaire Saint Etienne
• Germany
  • Bonn, Germany
    • Universitätsklinikum Bonn
  • Rostock, Germany
    • Universitätsklinikum Rostock Anstalt öffentlichen Rechts und Medizinische Fakultät der Universität
  • Ulm, Germany
    • Universitätsklinikum Ulm
• Hungary
  • Budapest, Hungary
    • Semmelweis Egyetem AOK
• Israel
  • Haifa, Israel
    • Rambam Health Care Campus
• Italy
  • Roma, Italy
    • Azienda Complesso Ospedaliero San Filippo Neri
  • Milano
    • San Donato Milanese, Milano, Italy
      • IRCCS Policlinico San Donato
• Netherlands
  • Amsterdam, Netherlands
    • VU Medisch Centrum
  • Amsterdam, Netherlands
    • Onze Lieve Vrouwe Gasthuis - Locatie Oosterpark
  • Den Haag, Netherlands
    • HagaZiekenhuis - Locatie Leyweg
  • Nieuwegein, Netherlands
    • St. Antonius Ziekenhuis
• Switzerland
  • Lausanne, Switzerland
    • Centre Hospitalier Universitaire Vaudois
  • Zürich, Switzerland
    • Universitatsspital Zurich
• United Kingdom
  • Bournemouth, United Kingdom
    • Royal Bournemouth Hospital
  • Manchester, United Kingdom
    • Wythenshawe Hospital
• United States
  • California
    • Salinas, California, United States, 93901-3901
      • Central Coast Cardiology
  • Florida
    • Orlando, Florida, United States, 32806-2014
      • Mid Florida Cardiology
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Iowa Heart Center
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Mid America Heart Institute
  • North Carolina
    • Raleigh, North Carolina, United States, 27610
      • Raleigh Cardiology Associates
  • Ohio
    • Cincinnati, Ohio, United States, 45219-2906
      • The Lindner Research Center
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Oklahoma Heart Institute
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Greenville Hospital System
  • Tennessee
    • Knoxville, Tennessee, United States, 37923-4310
      • Cardiology Associates of East Tennesee
  • Texas
    • Dallas, Texas, United States, 75226-1300
      • Baylor Heart & Vascular Hosptial
  • Virginia
    • Charlottesville, Virginia, United States, 22908-0816
      • University of Virginia Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Model 5086 MRI lead

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Magnetic Resonance Imaging (MRI)-Related Complications	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.	MRI scan to one-month post-MRI scan
Atrial Pacing Capture Threshold Success	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.	Pre-MRI/waiting period to one month post-MRI/waiting period
Ventricular Pacing Capture Threshold Success	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.	Pre-MRI /waiting period to 1-month post-MRI/waiting period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial Sensed Amplitude Success	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.	Pre-MRI /waiting period to 1-month post-MRI/waiting period
Ventricular Sensed Amplitude Success	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.	Pre-MRI /waiting period to 1-month post-MRI/waiting period
Occurrence of Sustained Ventricular Arrhythmias and Asystole 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.	During MRI scans
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 the AEAC. The AEAC determined whether each adverse event was a complication (requiring invasive intervention), and whether the event was related to the system.	Implant to four months post implant

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: Study Chair: Advisa MRI Trial Leader, Medtronic

Publications and helpful links

General Publications

• Gimbel JR, Bello D, Schmitt M, Merkely B, Schwitter J, Hayes DL, Sommer T, Schloss EJ, Chang Y, Willey S, Kanal E; Advisa MRI System Study Investigators. Randomized trial of pacemaker and lead system for safe scanning at 1.5 Tesla. Heart Rhythm. 2013 May;10(5):685-91. doi: 10.1016/j.hrthm.2013.01.022. Epub 2013 Jan 17.
• Schwitter J, Kanal E, Schmitt M, Anselme F, Albert T, Hayes DL, Bello D, Toth A, Chang Y, van Osch D, Sommer T; Advisa MRI System Study Investigators. Impact of the Advisa MRI pacing system on the diagnostic quality of cardiac MR images and contraction patterns of cardiac muscle during scans: Advisa MRI randomized clinical multicenter study results. Heart Rhythm. 2013 Jun;10(6):864-72. doi: 10.1016/j.hrthm.2013.02.019. Epub 2013 Feb 19.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (ACTUAL): March 1, 2012
• Study Completion (ACTUAL): March 1, 2013

Study Registration Dates

• First Submitted: April 23, 2010
• First Submitted That Met QC Criteria: April 23, 2010
• First Posted (ESTIMATE): April 27, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): April 30, 2013
• Last Update Submitted That Met QC Criteria: April 23, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: AdvisaMRI