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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02787291
Recruitment Status : Completed
First Posted : June 1, 2016
Results First Posted : September 3, 2020
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

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

Condition or disease Intervention/treatment Phase
Implantable Defibrillator User Device: Ellipse VR ICD and Durata/Optisure lead Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 227 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 2016
Actual Primary Completion Date : January 12, 2017
Actual Study Completion Date : April 11, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Number of Participants With MRI Scan Related Complications [ Time Frame: 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.

  2. Percentage of Participants With Ventricular Capture Threshold ≤ to 0.5V [ Time Frame: 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.

  3. Percentage of Participants With Ventricular Sensing Amplitude Decrease of ≤ 50% From Pre-MRI Scan to 1 Month Post MRI Scan [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787291


Locations
Show Show 32 study locations
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Chair: Saman Nazarian, MD Johns Hopkins University Hospital
  Study Documents (Full-Text)

Documents provided by Abbott Medical Devices:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02787291    
Other Study ID Numbers: SJM-CIP-CRD768
First Posted: June 1, 2016    Key Record Dates
Results First Posted: September 3, 2020
Last Update Posted: September 3, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No