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Completed

NCT Number: NCT02787291

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

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

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Key information

Conditions

Implantable Defibrillator User

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Semmelweis University, Budapest, Hungary

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ellipse VR ICD and Durata/Optisure lead

Device

Non-diagnostic MRI Scan sequence of head and chest

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study 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

Acronym: MRI Ready IDE

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jun 1, 2016
Registry last updated
Sep 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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