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

NCT03012568 | Completed

• 1 other identifier: SJM-CIP-10137
• Study Type: observational
• Target: 119
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

Bradycardia; Tachycardia

Outcome Measures

Primary Outcomes (1)

• Safety Endpoint: Freedom from MRI scan-related complications

  One month following the MRI scan.

Interventions

SJM Implantable cardiac devices DEVICE

SJM implantable devices undergoing MRI scan

Also known as: ICD, CRT-D, Pacemakers, CRT, MRI, Leads

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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:
• Accent MRI™, Assurity MRI™, Endurity MRI™, or Endurity pacemaker with Tendril™ STS Model 2088 lead
• Accent MRI™, Assurity MRI™, Endurity MRI™, or Endurity pacemaker with IsoFlex™ Optim (Model 1944 or 1948) lead
• Ellipse™ VR/DR or Fortify Assura VR/DR ICD with Tendril™ STS (Model 2088) or Tendril MRI™ and Durata™ or Optisure™ leads
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (3)

Heart Care Partners - Wesley Hospital

Auchenflower, Queensland, 4066, Australia

Location

Heart Care Western Australia

Perth, Western Australia, 6000, Australia

Location

CARE Banjara

Hyderabad, Andhra Pradesh, 500034, India

Location

MeSH Terms

Conditions

Bradycardia; Tachycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Conduction System Disease

Study Officials

• Grant Kim

  Abbott Medical Devices

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: January 6, 2017
• Study Start: November 10, 2016
• Primary Completion: January 26, 2018
• Study Completion: March 29, 2018
• Last Updated: August 5, 2019

Record last verified: 2019-08

Locations

AU (2); IN (1)