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

  • STATUS
    Not Recruiting
  • participants needed
    88
  • sponsor
    St. Jude Medical
Updated on 23 January 2021
combinations
cardiac resynchronization therapy

Summary

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.

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.

Details
Condition Bradycardia, Tachycardia
Treatment SJM Implantable cardiac devices
Clinical Study IdentifierNCT03012568
SponsorSt. Jude Medical
Last Modified on23 January 2021

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