Magnetic Resonance ImagingNCT01110915
Advisa MRI Clinical Study
A study testing Medtronic Advisa MRI Implantable Pulse Generator (IPG) and Medtronic CapSureFix MRI™ active fixation MRI lead in people with Magnetic Resonance Imaging and Cardiac Pacemaker, Artificial, run by Medtronic Cardiac Rhythm and Heart Failure at 37 sites in 13 countries.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Magnetic Resonance Imaging, Cardiac Pacemaker, Artificial
- What is being tested?
- Medtronic Advisa MRI Implantable Pulse Generator (IPG) and Medtronic CapSureFix MRI™ active fixation MRI lead
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 269 participants
- Where
- 37 sitesin 13 countries
- Study dates
- Jun 2010to Mar 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
37 sites in 13 countries.
37 sites in 13 countries
United States11 sites
University of Virginia Health System
Charlottesville, Virginia, 22908-0816
The Lindner Research Center
Cincinnati, Ohio, 45219-2906
Baylor Heart & Vascular Hosptial
Dallas, Texas, 75226-1300
Greenville Hospital System
Greenville, South Carolina, 29605
Mid America Heart Institute
Kansas City, Missouri, 64111
Cardiology Associates of East Tennesee
Knoxville, Tennessee, 37923-4310
Mid Florida Cardiology
Orlando, Florida, 32806-2014
Raleigh Cardiology Associates
Raleigh, North Carolina, 27610
Central Coast Cardiology
Salinas, California, 93901-3901
Oklahoma Heart Institute
Tulsa, Oklahoma, 74104
Iowa Heart Center
West Des Moines, Iowa, 50266
Australia4 sites
Adelaide Cardiology
Adelaide, South Australia
The Prince Charles Hospital
Chermside, Queensland
St. George Hospital
Kogarah, New South Wales
Epworth
Richmond, Victoria
Netherlands4 sites
Onze Lieve Vrouwe Gasthuis - Locatie Oosterpark
Amsterdam
VU Medisch Centrum
Amsterdam
St. Antonius Ziekenhuis
Nieuwegein
HagaZiekenhuis - Locatie Leyweg
The Hague
France3 sites
CHRU Hôpital Arnaud de Villeneuve
Montpellier
CHU Hôpiteaux de Rouen
Rouen
Centre Hospitalier Universitaire Saint Étienne
Saint-Etienne
Germany3 sites
Universitätsklinikum Bonn
Bonn
Universitätsklinikum Rostock Anstalt öffentlichen Rechts und Medizinische Fakultät der Universität
Rostock
Universitätsklinikum Ulm
Ulm
Canada2 sites
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
Québec, Quebec, G1V 4G5
Italy2 sites
Azienda Complesso Ospedaliero San Filippo Neri
Roma
IRCCS Policlinico San Donato
San Donato Milanese, Milano
Switzerland2 sites
Centre Hospitalier Universitaire Vaudois
Lausanne
UniversitätsSpital Zürich
Zurich
United Kingdom2 sites
Royal Bournemouth Hospital
Bournemouth
Wythenshawe Hospital
Manchester
About this study
Official title: 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).
Read the 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.
- Being tested
- Medtronic Advisa MRI Implantable Pulse Generator (IPG), Medtronic CapSureFix MRI™ active fixation MRI lead
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Advisa MRI Implantable Pulse Generator (IPG)Device
Also called Model A2DR01, Model A3DR01
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.
Medtronic CapSureFix MRI™ active fixation MRI leadDevice
Also called Model 5086 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.
| Study group | Role | What they receive |
|---|---|---|
| MRI group | Experimental | 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. Receives: Device: Medtronic Advisa MRI Implantable Pulse Generator (IPG); Device: Medtronic CapSureFix MRI™ active fixation MRI lead |
| Control group | Active comparator | Subjects randomized to the Control group will wait for one hour without having any MRI scan at 9-12 weeks post-implant. Receives: Device: Medtronic Advisa MRI Implantable Pulse Generator (IPG); Device: Medtronic CapSureFix MRI™ active fixation MRI lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Pre-MRI /waiting period to 1-month post-MRI/waiting period
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Implant to four months post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (estimated)
- Study startJun 2010
- Primary completionMar 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Magnetic Resonance ImagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Advisa MRI Trial Leader, Study chair, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110915
- Sponsor's protocol ID
- AdvisaMRI
- Status last verified
- Apr 2013
- First submitted
- 23 Apr 2010
- Last updated
- 30 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 23333721Schwitter 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.
PubMed 23434621
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advisa MRI™ System Clinical Investigation
- ClinicalTrials.gov ID
- NCT01110915
- Acronym / sponsor ID
- AdvisaMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 27 Apr 2010 (estimated)
- Results
- Posted 4 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRI group | Experimental | Device: Medtronic Advisa MRI Implantable Pulse Generator (IPG), Device: Medtronic CapSureFix MRI™ active fixation MRI leadSubjects 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. |
| Control group | Active comparator | Device: Medtronic Advisa MRI Implantable Pulse Generator (IPG), Device: Medtronic CapSureFix MRI™ active fixation MRI leadSubjects randomized to the Control group will wait for one hour without having any MRI scan at 9-12 weeks post-implant. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic Advisa MRI Implantable Pulse Generator (IPG)Also: Model A2DR01, Model A3DR01Advisa 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. | Device | Control group, MRI group |
| Medtronic CapSureFix MRI™ active fixation MRI leadAlso: Model 5086 MRI leadThe 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. | Device | Control group, MRI group |
Primary outcome
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.
4 secondary outcomes
Atrial Sensed Amplitude Success
Time frame: Pre-MRI /waiting period to 1-month post-MRI/waiting period
Ventricular Sensed Amplitude Success
Time frame: Pre-MRI /waiting period to 1-month post-MRI/waiting period
Occurrence of Sustained Ventricular Arrhythmias and Asystole During MRI Scans.
Time frame: During MRI scans
System-related Complications
Time frame: Implant to four months post implant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23333721Gimbel 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.
- Results publication: PubMed 23434621Schwitter 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Advisa MRI Trial Leader study chair
Medtronic
37 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic Advisa MRI Implantable Pulse Generator (IPG) and Medtronic CapSureFix MRI™ active fixation MRI lead in people with Magnetic Resonance Imaging and Cardiac Pacemaker, Artificial, run by Medtronic Cardiac Rhythm and Heart Failure at 37 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Australia, Netherlands, France, Germany and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnetic Resonance Imaging (MRI)-Related Complications (time frame: MRI scan to one-month post-MRI scan). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01110915, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2013.