Advisa MRI Clinical Study

Not Applicable

Completed

Conditions: Magnetic Resonance Imaging
Cardiac Pacemaker, Artificial

Interventions: Device: Medtronic Advisa MRI Implantable Pulse Generator (IPG)
Device: Medtronic CapSureFix MRI™ active fixation MRI lead

Registration Number: NCT01110915

Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 269

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MRI group	Medtronic Advisa MRI Implantable Pulse Generator (IPG)	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.
Control group	Medtronic Advisa MRI Implantable Pulse Generator (IPG)	Subjects randomized to the Control group will wait for one hour without having any MRI scan at 9-12 weeks post-implant.
Control group	Medtronic CapSureFix MRI™ active fixation MRI lead	Subjects randomized to the Control group will wait for one hour without having any MRI scan at 9-12 weeks post-implant.
MRI group	Medtronic CapSureFix MRI™ active fixation MRI lead	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.

Primary Outcome Measures

Name	Time	Method
Magnetic Resonance Imaging (MRI)-Related Complications	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	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	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.

Secondary Outcome Measures

Name	Time	Method
System-related Complications	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.
Ventricular Sensed Amplitude Success	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.	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.
Atrial Sensed Amplitude Success	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.

Trial Locations

Locations (37): Onze Lieve Vrouwe Gasthuis - Locatie Oosterpark
🇳🇱
Amsterdam, Netherlands
VU Medisch Centrum
🇳🇱
Amsterdam, Netherlands
IRCCS Policlinico San Donato
🇮🇹
San Donato Milanese, Milano, Italy
Azienda Complesso Ospedaliero San Filippo Neri
🇮🇹
Roma, Italy
Rambam Health Care Campus
🇮🇱
Haifa, Israel
Universitätsklinikum Rostock Anstalt öffentlichen Rechts und Medizinische Fakultät der Universität
🇩🇪
Rostock, Germany
Royal Bournemouth Hospital
🇬🇧
Bournemouth, United Kingdom
Universitätsklinikum Ulm
🇩🇪
Ulm, Germany
Semmelweis Egyetem AOK
🇭🇺
Budapest, Hungary
Wythenshawe Hospital
🇬🇧
Manchester, United Kingdom
HagaZiekenhuis - Locatie Leyweg
🇳🇱
Den Haag, Netherlands
St. Antonius Ziekenhuis
🇳🇱
Nieuwegein, Netherlands
Central Coast Cardiology
🇺🇸
Salinas, California, United States
Iowa Heart Center
🇺🇸
West Des Moines, Iowa, United States
Raleigh Cardiology Associates
🇺🇸
Raleigh, North Carolina, United States
Oklahoma Heart Institute
🇺🇸
Tulsa, Oklahoma, United States
Cardiology Associates of East Tennesee
🇺🇸
Knoxville, Tennessee, United States
Greenville Hospital System
🇺🇸
Greenville, South Carolina, United States
Baylor Heart & Vascular Hosptial
🇺🇸
Dallas, Texas, United States
Adelaide Cardiology
🇦🇺
Adelaide, South Australia, Australia
The Prince Charles Hospital
🇦🇺
Chermside, Queensland, Australia
Epworth
🇦🇺
Richmond, Victoria, Australia
Hôpital Saint-Joseph
🇧🇪
Gilly, Belgium
Montreal Heart Institute
🇨🇦
Montreal, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
🇨🇦
Quebec, Canada
CHRU Hôpital Arnaud de Villeneuve
🇫🇷
Montpellier, France
CHU Hôpiteaux de Rouen
🇫🇷
Rouen Cedex, France
Universitätsklinikum Bonn
🇩🇪
Bonn, Germany
Centre Hospitalier Universitaire Saint Étienne
🇫🇷
Saint Etienne, France
Landesklinikum St. Pölten
🇦🇹
Sankt Pölten, Austria
Centre Hospitalier Universitaire Vaudois
🇨🇭
Lausanne, Switzerland
UniversitätsSpital Zürich
🇨🇭
Zürich, Switzerland
The Lindner Research Center
🇺🇸
Cincinnati, Ohio, United States
Mid Florida Cardiology
🇺🇸
Orlando, Florida, United States
Mid America Heart Institute
🇺🇸
Kansas City, Missouri, United States
University of Virginia Health System
🇺🇸
Charlottesville, Virginia, United States
St. George Hospital
🇦🇺
Kogarah, New South Wales, Australia