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

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General Information

Age Group

Adults

Status

Active

Protocol Number

ABT-CIP-10262

Background Information

Brief 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.

Detailed 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 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 used to confirm DBS electrode placement or prescribed for diagnostic purposes.

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) after the MRI procedure is performed.

Offered At

Inova Medical Group – Neurology
1500 N Beauregard Street, Suite #300
Alexandria, VA 22311

Principal Investigator

Drew Falconer, MD

Eligibility Information

  • Subject, or a legally acceptable representative, must provide written informed consent prior to any clinical investigation related procedure.
  • Subject has been implanted, or is scheduled to be implanted, with a commercially available Infinity DBS system with MR Conditional labeling.
  • Subject is scheduled to undergo a MRI procedure in compliance with the MRI Procedure Information Clinican's Manual.
  • Subject is willing and able to comply with study requirements.

Ineligibility Information

  • Subject has another implanted device that prohibits safe scanning.
  • Subject has previously experienced an MRI-related adverse event or cannot undergo MRI for any other reason.
  • Subject is pregnant or nursing, or plans to become pregnant during the clinical investigation follow-up period.
  • Subject has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that could limit ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the results.
  • Subject is participating in another clinical investigation that may confound the results of this study.

For more information, visit clinicaltrials.gov