A Clinical Evaluation of the Durata or Optisure High Voltage Leads and Ellipse VR ICD Undergoing MRI, an IDE Study

Study Overview
=================
Brief Summary
-----------------
To demonstrate safety and efficacy of the Durata or Optisure high voltage lead and Ellipse VR ICD in an MRI environment.

Detailed Description
-----------------
The intent of this IDE study is to evaluate the safety and efficacy of the Durata or Optisure lead and Ellipse VR ICD that have undergone an MRI scan. The patient population under study includes patients indicated for or who have been implanted with a Durata or Optisure lead and an Ellipse VR ICD.

Official Title
-----------------
A Clinical Evaluation of the Durata or Optisure High Voltage Leads and Ellipse VR ICD Undergoing Magnetic Resonance Imaging, an Investigational Device Exemption (IDE) Study

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

Intervention / Treatment
-----------------
* Device: Ellipse VR ICD and Durata/Optisure lead


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are implanted with the Durata or Optisure lead for at least 60 days (can include patients with Durata or Optisure lead for > 60 days OR patients with a new Ellipse VR ICD and/or Durata/Optisure lead implanted for at least 60 days Are implanted with an Ellipse VR ICD pectorally Be willing to undergo an elective MRI scan without sedation NOTE: Antianxiety agents (e.g. minor tranquilizers, etc.) may be used as long as the patient can communicate with site personnel during the MRI scan Capture threshold is stable < 2.5V @ 0.5ms Ventricular sensing is measurable (patient has underlying rhythm > 30bpm) and the sensing amplitude is > 4mV Be able to provide informed consent for study participation (legal guardian or legally authorized representative is NOT acceptable) Be willing and able to comply with the prescribed follow-up tests and procedures Are not contraindicated for an MRI scan (per the MRI Screening Form) Exclusion Criteria: Have a competitor's MRI compatible endocardial lead implanted or capped Have another existing active implanted medical device, e.g., neurostimulator, infusion pump, etc., that has MR labeling that will not allow the MRI scans per this protocol to be completed. Have a lead revision of the Durata/Optisure lead occur < 60 days of the baseline visit Have other non-MRI compatible device or material implanted NOTE: MRI compatible knee replacements, hip replacements, stents, etc. may be included as long as the labeling of these devices allow MRI scans conducted per this protocol NOTE: MRI compatible mechanical, prosthetic, and bioprosthetic heart valves may be included as long as the labeling of these devices allow for MRI scans conducted per this protocol NOTE: Non-removable dental implants may be included Have a lead extender, adaptor, or capped/abandoned lead Enrolled or intend to participate in a clinical drug and/or device study (investigational device, investigational drug, new indication for a device or drug or additional testing beyond standard of care procedures), which could confound the results of this trial as determined by SJM. Pregnant or planning to become pregnant during the duration of the subject's participation in the study Have a life expectancy of less than 12 months due to any condition Patients with exclusion criteria required by local law (e.g., age)

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ellipse VR ICD and Durata/Optisure lead<br>Pts with Ellipse VR ICD and Durata or Optisure RV lead implanted for at least 60 days will receive a non-diagnostic MRI scan of head and chest region | Device: Ellipse VR ICD and Durata/Optisure lead<br>* Non-diagnostic MRI Scan sequence of head and chest<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With MRI Scan Related Complications | The primary safety endpoint is the number of participants that had an Ellipse ICD and/or a Durata or Optisure lead complication from the day the MRI scan occurred to the 1-month visit. A complication is defined as a serious adverse device effect that requires an invasive intervention or leads to death. | MRI scan to 1 month post MRI scan | 
| Percentage of Participants With Ventricular Capture Threshold ≤ to 0.5V | Percentage of participants of Durata or Optisure (RV) leads implanted with the Ellipse VR ICD with capture threshold increase of ≤ 0.5V at 0.5ms from pre-MRI scan to 1 month post-MRI scan. | pre-MRI scan to 1 month post MRI scan | 
| Percentage of Participants With Ventricular Sensing Amplitude Decrease of ≤ 50% From Pre-MRI Scan to 1 Month Post MRI Scan | Percentage of Participants with Durata or Optisure RV leads implanted with the Ellipse VR ICD with sensing amplitude decrease of ≤ 50% from pre-MRI scan to 1 month post MRI scan. | pre-MRI scan to 1 month post MRI scan |