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

Completed · Not applicable

Conditions studied: Implantable Defibrillator User

In brief

To demonstrate safety and efficacy of the Durata or Optisure high voltage lead and Ellipse VR ICD in an MRI environment.

Key facts

Study ID

NCT02787291

Run by

Abbott Medical Devices

People needed

227

Starts

2016-05-01

Expected to finish

2018-04-11

Last updated by the study team

2020-09-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• 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
• Sparrow Clinical Research Institute — Lansing, Michigan, United States
• Providence Hospital — Southfield, Michigan, United States
• Jackson Heart Clinic — Jackson, Mississippi, United States
• St. Francis — Roslyn, New York, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Samaritan Heart & Vascular Institute — Corvallis, Oregon, United States
• Saint Vincent Consultants in Cardiovascular Diseases — Erie, Pennsylvania, United States
• Pinnacle Health System — Harrisburg, Pennsylvania, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Donald Guthrie Foundation for Education and Research — Sayre, Pennsylvania, United States
• Methodist University Hospital — Memphis, Tennessee, United States
• St. Thomas Hospital — Nashville, Tennessee, United States
• Baylor All Saints Medical Center at Fort Worth — Fort Worth, Texas, United States
• West Virginia University Hospital — Morgantown, West Virginia, United States
• Aurora Medical Group — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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