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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03884231
Other study ID # ABT-CIP-10262
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 10, 2019
Est. completion date August 20, 2021

Study information

Verified date June 2022
Source Abbott Medical Devices
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a study of subjects with the St. Jude Medical Infinity deep brain stimulation (DBS) system who undergo an MRI imaging procedure. Enrollment may occur before DBS implant, or when an MRI scan is planned in a subject with an existing implant. There will be a follow-up visit one month after the MRI procedure to document any adverse events and verify device functionality.


Description:

This study will be conducted as an international, multicenter,observational, prospective, single-arm, post-market clinical follow-up (PMCF). The study will evaluate the safety of the Infinity DBS system with MR Conditional labeling when an MRI procedure is performed according to the approved guidance. The study will enroll approximately 74 subjects at up to 25 centers in geographies where Infinity DBS systems with MR Conditional labeling is approved, including the European Union and the United States. Subjects who have a leads-only configuration or a full system configuration will participate in the study. Subjects may be enrolled when an MRI procedure is prescribed per standard of care. Each subject will be limited to one MRI procedure during the course of the study. Data collected include MRI parameters and any adverse events that occur during or after the procedure. There will be an office visit to document any adverse events and verify device functionality for all subjects one month (30 days ± 14 days) post-MRI follow-up visit after the initial MRI procedure is performed.


Recruitment information / eligibility

Status Completed
Enrollment 71
Est. completion date August 20, 2021
Est. primary completion date July 22, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. Subject or subject's legally acceptable representative must provide written informed consent prior to any clinical investigation related procedure. 2. Subject has been implanted, or is scheduled to be implanted, with a commercially available Infinity DBS system with MR Conditional labeling per locally approved indications for use. 3. Subject is scheduled to undergo a MRI procedure in compliance with the MRI Procedure Information Clinician's Manual. Anxiolytics and patient's regular medications may be administered, provided Instructions For Use (IFU) criteria are met. 4. Subject is willing and able to comply with study requirements. Exclusion Criteria: 1. Subject has another implanted device (active or passive implanted device) that prohibits safe scanning. 2. Subject has previously experienced an MRI-related adverse event or cannot undergo MRI for any other reason. 3. Subject is pregnant or nursing, or plans to become pregnant during the clinical investigation follow-up period. 4. Subject has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results. 5. Subject is currently participating in another clinical investigation that may confound the results of this study.

Study Design


Intervention

Device:
Infinity DBS System with MR Conditional labelling (Leads-only configuration)
Patients will undergo MRI procedures using Leads-only configuration
Infinity DBS System with MR Conditional labelling (Full system configuration)
Patients will undergo MRI procedures using Full system configuration

Locations

Country Name City State
France CHU Gabriel Montpied Clermont-Ferrand Auverg N
Germany Medizinische Einrichtungen der Universität Düsseldorf Düsseldorf N. Rhin
Germany UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz Mainz Rhinela
Germany Universitäts Klinikum Tübingen Tübingen Bad-wur
Spain Hospital Universitario de la Princesa Madrid
Sweden Universitetsjukhuset I Lund Lund Skane
Sweden Akademiska sjukhuset Uppsala Uppland
United States Emory University Hospital Atlanta Georgia
United States University of Colorado Hospital Aurora Colorado
United States Wright State University & Premier Health Fairborn Ohio
United States Inova Fairfax Hospital Falls Church Virginia
United States Neurosurgery One Littleton Colorado
United States Robert Wood Johnson University Hospital New Brunswick New Jersey
United States Willis-Knighton Medical Center Shreveport Louisiana
United States Inland Northwest Research Spokane Washington
United States Banner University Medical Center Tucson Campus Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  France,  Germany,  Spain,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary MRI-related adverse events The primary outcome is the rate of MRI-related adverse events. From MRI procedure through 1 month post-MRI procedure.
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