Evaluation of Approved Pacing Lead (Model 5076) for Use in MRI Environment

Study Overview
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Brief Summary
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The purpose of this study is to test the safety and effectiveness of the Medtronic CapSureFix Novus Model 5076 lead when patients are implanted with the Medtronic Advisa MRI pacemaker and undergo an MRI scan.

Official Title
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CapSureFix® Novus Model 5076 Lead MRI Study

Conditions
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Magnetic Resonance Imaging (MRI), Cardiac Pacing

Intervention / Treatment
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* Other: Magnetic Resonance Imaging scan sequences of the head, neck, and chest
* Device: Pacemaker System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who have Class I and II indication for implantation of a dual chamber pacemaker according to the ACC/AHA/HRS guidelines Subjects who are able to undergo a pectoral implant Subjects who: are receiving an IPG for the first time, OR are receiving a replacement IPG connected to two previously- implanted (atrial and ventricular) Model 5076 leads Subjects who are able and willing to undergo elective MRI scanning without sedation Subjects who are geographically stable and available for follow-up at the study site 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 1.0mg dexamethasone acetate may be contraindicated. Subjects who require a legally authorized representative to obtain consent. Subjects who have abandoned (inactive) pacemaker and/or defibrillator leads Subjects who are immediate candidates for an ICD. Subjects who require an indicated MRI scan, other than those specifically described in the study, before the one-month post MRI/waiting period follow-up. Subjects with previously implanted active medical devices (exception Model 5076 Lead and Advisa MRI IPG). 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
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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 Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant. | Other: Magnetic Resonance Imaging scan sequences of the head, neck, and chest<br> <br> Device: Pacemaker System<br> <br> * Other names: Advisa MRI Pacemaker;|
| Sham Comparator: Control Group<br>Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit. | Device: Pacemaker System<br> <br> * Other names: Advisa MRI Pacemaker;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI-related Complication Free Rate | Number of patients free of MRI-related complications | MRI scan to one month later | 
| Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Atrial Voltage Thresholds | 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 (9-12 weeks post implant) to one month post-MRI/waiting period | 
| Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Ventricular Voltage Thresholds | 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 (9-12 weeks post implant) to one month post-MRI/waiting period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Atrial Sensing Amplitude | 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 (9-12 weeks post-implant) 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 Adverse Events Adjudication Committee | During MRI scans (9-12 weeks post-implant) | 
| Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Ventricular Sensing Amplitude | 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 (9-12 weeks post implant) to one month post-MRI/waiting period |