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

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

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

Study Overview

• Status: Completed
• Conditions: Implantable Defibrillator User
• Intervention / Treatment: Device: Ellipse VR ICD and Durata/Optisure lead

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.

• Study Type: Interventional
• Enrollment (Actual): 227
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary
    • Semmelweis University
• Poland
  • Silesia
    • Poznan, Silesia, Poland
      • Szpital Kliniczny Premienienia Panskiego
    • Tychy, Silesia, Poland
      • American Heart of Poland SA
  • Voivode
    • Krakow, Voivode, Poland
      • Carint Scanmed Sp. z.o.o.
• Spain
  • Castellon
    • Salamanca, Castellon, Spain
      • Hospital Universitario de Salamanca
• United Kingdom
  • West Dunbartonshire
    • Clydebank, West Dunbartonshire, United Kingdom
      • Golden Jubilee National Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States
      • John C. Lincoln North Mountain Hospital
  • California
    • Bakersfield, California, United States
      • Central Cardiology
    • La Jolla, California, United States
      • Scripps Health
  • Florida
    • Orlando, Florida, United States
      • Florida Hospital
  • Georgia
    • Athens, Georgia, United States
      • Athens Regional Medical Center
    • Rome, Georgia, United States
      • Redmond Regional Medical Center
  • Illinois
    • Springfield, Illinois, United States
      • Prairie Education And Research Cooperative
  • Indiana
    • Fort Wayne, Indiana, United States
      • Parkview Research Center
    • Muncie, Indiana, United States
      • Medical Consultants
  • Massachusetts
    • Boston, Massachusetts, United States
      • Massachusetts General Hospital
  • Michigan
    • Lansing, Michigan, United States
      • Sparrow Clinical Research Institute
    • Southfield, Michigan, United States
      • Providence Hospital
  • Mississippi
    • Jackson, Mississippi, United States
      • Jackson Heart Clinic
  • New York
    • Roslyn, New York, United States
      • St. Francis
  • Ohio
    • Cleveland, Ohio, United States
      • The Cleveland Clinic Foundation
  • Oregon
    • Corvallis, Oregon, United States
      • Samaritan Heart & Vascular Institute
  • Pennsylvania
    • Erie, Pennsylvania, United States
      • Saint Vincent Consultants in Cardiovascular Diseases
    • Harrisburg, Pennsylvania, United States
      • Pinnacle Health System
    • Hershey, Pennsylvania, United States
      • Penn State Milton S. Hershey Medical Center
    • Sayre, Pennsylvania, United States
      • Donald Guthrie Foundation for Education and Research
  • Tennessee
    • Memphis, Tennessee, United States
      • Methodist University Hospital
    • Nashville, Tennessee, United States
      • St. Thomas Hospital
  • Texas
    • Fort Worth, Texas, United States
      • Baylor All Saints Medical Center at Fort Worth
  • West Virginia
    • Morgantown, West Virginia, United States
      • West Virginia University Hospital
  • Wisconsin
    • Milwaukee, Wisconsin, United States
      • Aurora Medical Group
    • Milwaukee, Wisconsin, United States
      • Cardiac Rhythm Specialists, S.C.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Ellipse VR ICD and Durata/Optisure lead; 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; Non-diagnostic MRI Scan sequence of head and chest

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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Chair: Saman Nazarian, MD, Johns Hopkins University Hospital

Publications and helpful links

General Publications

• Nazarian S, Cantillon DJ, Woodard PK, Mela T, Cline AM, Strickberger AS; MRI Ready Investigators. MRI Safety for Patients Implanted With the MRI Ready ICD System: MRI Ready Study Results. JACC Clin Electrophysiol. 2019 Aug;5(8):935-943. doi: 10.1016/j.jacep.2019.05.010. Epub 2019 Jun 26.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): January 12, 2017
• Study Completion (Actual): April 11, 2018

Study Registration Dates

• First Submitted: May 20, 2016
• First Submitted That Met QC Criteria: May 26, 2016
• First Posted (Estimate): June 1, 2016

Study Record Updates

• Last Update Posted (Actual): September 3, 2020
• Last Update Submitted That Met QC Criteria: August 19, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: SJM-CIP-CRD768

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No