Clinical Study to Confirm MRI Safety and Effectiveness Using St. Jude Medical (SJM) Cardiac Rhythm Management Systems (ASSUREMRI)

August 2, 2019 updated by: Abbott Medical Devices

ASSURE MRI Study - Clinical Study to Confirm MRI Safety and Effectiveness Using St. Jude Medical (SJM) Cardiac Rhythm Management Systems

This is a clinical investigational plan (CIP) for the "Clinical Study to Confirm MRI Safety and Effectiveness Using SJM Cardiac Rhythm Management Systems (ASSURE MRI)". This study intends to enroll patients who meet standard bradycardia or tachycardia indications and have already been implanted with one of the SJM device/lead combinations listed in this protocol. The objective of this study is to confirm the safety and effectiveness of each of the four SJM device/lead combinations in an MRI environment. This clinical investigation is sponsored by St. Jude Medical.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, multi-center clinical study designed to confirm the safety and effectiveness of St. Jude Medical low voltage pacemakers, high voltage dual chamber Implantable Cardioverter-Defibrillators (ICD), and Cardiac Resynchronization Therapy Defibrillators (CRT-D) with various leads in an MRI environment.

The study will enroll subjects across multiple geographies and sites. Sites in geographies where MRI labelling is not yet approved may also be included after appropriate IRB/EC and local regulatory approvals, as applicable, are obtained. A prospective, multi-center study design is chosen for generalizability of study results.

The clinical study will be conducted in approximately 40 centers worldwide. Approximately 88 subjects total (with a minimum 22 subjects for each of the four device/lead combinations) will be enrolled in this study.

Enrollment in the study is expected to take approximately 6-8 months. Subjects will be followed for 1 month following the MRI scan. The total study duration of the study is expected to be 10 months, depending on the rate of enrollment.

Study Type

Observational

Enrollment (Actual)

119

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • Heart Care Partners - Wesley Hospital
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Heart Care Western Australia
  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500034
        • CARE Banjara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who meet standard bradycardia or tachycardia indications comprise the target population for this study. The subject will be considered enrolled in the study after the consent is signed and the MRI Settings have been programmed at the MRI visit.

Description

Inclusion Criteria:

  • Are implanted with one of the following SJM device/lead combinations evaluated in this study for at least 60 days (can include patients with an eligible SJM lead for ≥ 60 days OR patients with a new eligible SJM pacemaker, Implantable Cardioverter-Defibrillators (ICD), or Cardiac Resynchronization Therapy Defibrillators (CRT-D) device and eligible SJM lead implanted for at least 60 days:

    1. Accent MRI™, Assurity MRI™, Endurity MRI™, or Endurity pacemaker with Tendril™ STS Model 2088 lead
    2. Accent MRI™, Assurity MRI™, Endurity MRI™, or Endurity pacemaker with IsoFlex™ Optim (Model 1944 or 1948) lead
    3. Ellipse™ VR/DR or Fortify Assura VR/DR ICD with Tendril™ STS (Model 2088) or Tendril MRI™ and Durata™ or Optisure™ leads
    4. Quadra Assura™ CRT-D with Tendril™ STS (Model 2088), Durata™ or Optisure™, and Quartet™ Quadripolar leads
  • Are implanted with an eligible SJM pacemaker, ICD, or CRT-D device 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 subject can communicate with site personnel during the MRI scan
  • Be able to provide informed consent for study participation (legal guardian is NOT acceptable)
  • Be willing and able to comply with the prescribed follow-up tests and schedule of evaluations

Exclusion Criteria:

  • 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 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
  • Be unable to fit in MRI bore, i.e., subject will come into contact with the magnet façade inside the MRI bore.
  • Are currently participating in a clinical investigation that includes an active treatment arm
  • Are pregnant or planning to become pregnant during the duration of the study
  • Have a life expectancy of less than 3 months due to any condition
  • Meet exclusion criteria per local law (e.g. age)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety Endpoint: Freedom from MRI scan-related complications
Time Frame: One month following the MRI scan.
One month following the MRI scan.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Study Director: Grant Kim, Abbott Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2016

Primary Completion (Actual)

January 26, 2018

Study Completion (Actual)

March 29, 2018

Study Registration Dates

First Submitted

January 5, 2017

First Submitted That Met QC Criteria

January 5, 2017

First Posted (Estimate)

January 6, 2017

Study Record Updates

Last Update Posted (Actual)

August 5, 2019

Last Update Submitted That Met QC Criteria

August 2, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJM-CIP-10137

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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