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

Not Applicable

Completed

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.

Recruitment & Eligibility

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)

Primary Outcome Measures

Name	Time	Method
Number of Participants With MRI Scan Related Complications	MRI scan to 1 month post MRI scan	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.
Percentage of Participants With Ventricular Capture Threshold ≤ to 0.5V	pre-MRI scan to 1 month post MRI scan	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.
Percentage of Participants With Ventricular Sensing Amplitude Decrease of ≤ 50% From Pre-MRI Scan to 1 Month Post MRI Scan	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.

Secondary Outcome Measures

Name	Time	Method

Locations (32): John C. Lincoln North Mountain Hospital
🇺🇸
Phoenix, Arizona, United States
Central Cardiology
🇺🇸
Bakersfield, California, United States
Scripps Health
🇺🇸
La Jolla, California, United States
Florida Hospital
🇺🇸
Orlando, Florida, United States
Athens Regional Medical Center
🇺🇸
Athens, Georgia, United States
Redmond Regional Medical Center
🇺🇸
Rome, Georgia, United States
Prairie Education and Research Cooperative
🇺🇸
Springfield, Illinois, United States
Parkview Research Center
🇺🇸
Fort Wayne, Indiana, United States
Medical Consultants
🇺🇸
Muncie, Indiana, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
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John C. Lincoln North Mountain Hospital
🇺🇸Phoenix, Arizona, United States