A Post-Market Study Evaluating the Safety of Infinity DBS System With MR Conditional Labeling

Parkinson Disease Clinical Trial

Official title:

A Post-Market Study Evaluating the Safety of Infinity DBS System With MR Conditional Labeling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03884231
• Other study ID #: ABT-CIP-10262
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Dystonia
• Essential Tremor
• Movement Disorders
• Parkinson Disease
• Tremor

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.