Advisa MRI Clinical Study

Study Overview
=================
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.

Official Title
-----------------
Advisa MRI™ System Clinical Investigation

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


Participation Criteria
=================
Eligibility 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)
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRI group<br>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)<br>* 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.<br>* Other names: Model A3DR01;Device: Medtronic CapSureFix MRI™ active fixation MRI lead<br>* 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.<br>* Other names: Model 5086 MRI lead;|
| Active Comparator: Control group<br>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)<br>* 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.<br>* Other names: Model A3DR01;Device: Medtronic CapSureFix MRI™ active fixation MRI lead<br>* 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.<br>* 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 |