Confirmatory Clinical Trial of the Evera MRI System for Conditionally-safe MRI Access

Study Overview
=================
Brief Summary
-----------------
The purpose of the Evera MRI™ study is to confirm safety and efficacy of the Evera MRI ICD (Implantable cardioverter-defibrillator) System in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans without positioning restrictions (MRI scans may occur anywhere on the body).

Official Title
-----------------
Evera MRI Clinical Study

Conditions
-----------------
Implantable Defibrillator

Intervention / Treatment
-----------------
* Device: MRI scan sequences of the head and chest regions
* Other: Waiting Period Visit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are indicated for implantation of an ICD at the time of study enrollment. Subjects who are able to undergo a pectoral implant. Subjects who are receiving an ICD for the first time. 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. Subjects who are at least 18 years of age (or older, if required by local law). Exclusion Criteria: Subjects with a history of significant tricuspid valvular disease . Subjects for whom a single dose of 1.0mg dexamethasone sodium phosphate and/or dexamethasone acetate may be contraindicated. Subjects who require a legally authorized representative to obtain informed consent. Subjects undergoing device upgrades, change-outs, lead extractions, and/or lead or device revisions. Subjects with abandoned or capped leads. Subjects who require an indicated MRI scan, other than those specifically described in the Evera MRI™ study, before the one-month post-MRI/waiting period follow-up (approximately 4 months post-implant). Subjects with a non-MRI compatible device (such as 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 study 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 the Evera MRI™ study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager. Female patient who is pregnant, or of childbearing potential and not on a reliable form of birth control. Women of childbearing potential are required to have a negative pregnancy test within seven (7) days prior to device implant. Subjects with exclusion criteria required by local law (e.g., age, breastfeeding).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

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 series of MRI scans at the MRI visit (9-12 weeks post-implant). | Device: MRI scan sequences of the head and chest regions<br>* Non-diagnostic MRI scans<br>|
| Sham Comparator: Control Group<br>Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant). | Other: Waiting Period Visit<br>* Waiting period time will equate to 1 hour<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI-related Events | Number of patients free of MRI-related events. Events include MRI-related complications, sustained tachyarrhythmia, and MRI-related loss of pacing ability. | MRI procedure to 1-month post-MRI | 
| Ventricular Pacing Capture Threshold (VPCT) | Number of successful patients, where success is defined as not increasing VPCT by more than 0.5V from pre-MRI/waiting to one month post. | Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit | 
| Ventricular Sensing Amplitude (R-wave) | Number of successful patients who do not experience a decrease in ventricular sensing amplitude of >50% from the pre-MRI/waiting period to the one month post-MRI/waiting period, or a one month post-MRI/waiting value <3mV accompanied by a decrease of >25% from the pre-MRI/waiting period to the one month post-MRI/waiting period. | Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System-related Complications | Number of subjects free of a system-related complication. The system includes the ICD and lead(s) attached to it. | Implant to 4 months post-implant | 
| RV Defibrillation Impedance | Number of subjects whose RV defibrillation impedance at the one-month post-MRI/waiting period visit is between 20 and 100 ohms | 1-month post-MRI/Waiting Period visit | 
| Superior Vena Cava (SVC) Defibrillation Impedance | Number of subjects whose SVC defibrillation impedance at the one-month post-MRI/waiting period visit is between 20 and 100 ohms | 1-month post-MRI/Waiting Period visit | 
| Atrial Pacing Capture Threshold (APCT) | Number of successful patients, where success is defined as not increasing APCT by more than 0.5V from pre-MRI/waiting to one month post. | Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit | 
| Atrial Sensing Amplitude | Number of successful patients, where success is defined as not decreasing atrial sensing amplitude by more than 50% from pre-MRI/waiting to one month post. | MRI/waiting visit to 1-month post-MRI/Waiting visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Magnetic Resonance Imaging (MRI)