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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03884231

Enrollment

Registered

2019-03-21

Start date

2019-04-10

Completion date

2021-08-20

Last updated

2024-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dystonia, Essential Tremor, Movement Disorders, Parkinson Disease, Tremor

Keywords

Infinity DBS system, ABT-CIP-1026, Deep Brain Stimulation, Magnetic resonance imaging

Brief summary

The Infinity MRI PMCF was conducted as an international, multicenter, observational, prospective, single-arm, post-market clinical follow-up (PMCF) study. The study evaluated the safety of the Infinity DBS system with MR Conditional labeling when an MRI procedure was performed according to the approved guidance. Subjects were followed for 1 month after the MRI procedure. Participation in the clinical study ended at the conclusion of the 1-month follow-up visit where subjects were then followed per standard of care.

Interventions

DEVICEInfinity DBS System with MR Conditional labelling

Patients implanted with the Infinity DBS system with MR Conditional labeling

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Rate of MRI-related Adverse Events	From MRI procedure through 1 month post-MRI procedure	Any adverse event that was included in the primary endpoint analysis, if it: 1. Was classified as being MRI-related (as determined by the CEC), occured during or after the MRI procedure, and cannot be attributed to any other cause; and 2. Was classified as being related to the device (implanted or external component) (as determined by the Investigator); and 3. Met the criteria for serious adverse event or was a non-serious adverse event that was the result of irrecoverable failure of therapy delivery or device communication.

Secondary

Measure	Time frame	Description
Rate of Successful MRI Mode 'Turn on/Off' Functionality of the MRI Mode	Immediately after the MRI scan	Secondary endpoints were evaluated after the MRI scan on subjects who were scanned with a full system configuration. Rate of successful MRI mode 'turn on/off' functionality of the MRI mode was assessed.
Rate of Successful 'Turn on/Off' Functionality for the Stimulation	Immediately after the MRI scan	Secondary endpoints were evaluated after the MRI scan on subjects who were scanned with a full system configuration. Rate of successful 'turn on/off' functionality for the stimulation was assessed.
Rate of Successful Adjustments to the Stimulation Amplitude	Immediately after the MRI scan	Secondary endpoints were evaluated after the MRI scan on subjects who were scanned with a full system configuration. Rate of successful adjustments to the stimulation amplitude was assessed.
Rate of Successful Interrogation and Download of the IPG Parameters	Immediately after the MRI scan	Secondary endpoints were evaluated after the MRI scan on subjects who were scanned with a full system configuration. Rate of successful interrogation and download of the IPG parameters was assessed.
Rate of Successful Ability to Obtain Lead Impedance Measurements	Immediately after the MRI scan	Secondary endpoints were evaluated after the MRI scan on subjects, who were scanned with a full system configuration. Rate of successful ability to obtain lead impedance measurements was assessed.

Countries

France, Germany, Spain, Sweden, United States

Participant flow

Recruitment details

The Infinity MRI PMCF has been conducted to evaluate the safety of Abbott's InfinityTM DBS Systems with MR conditional labeling. A total, 74 subjects were enrolled at 15 clinical sites located in Europe and the US.

Participants by arm

Arm	Count
Infinity DBS System With MR Conditional Labeling Patients implanted with the Infinity DBS system with MR Conditional labeling	74
Total	74

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	MRI Scan Not Performed	1
Overall Study	Subject Did Not Meet Inclusion/Exclusion Criteria	1
Overall Study	Subject Withdrew Consent	1

Baseline characteristics

Characteristic	Infinity DBS System With MR Conditional Labeling	—
Age, Continuous	63.4 years STANDARD_DEVIATION 9.8	—
Number of participants with Primary Indication for DBS Dystonia	1 Participants	—
Number of participants with Primary Indication for DBS Essential Tremor	22 Participants	—
Number of participants with Primary Indication for DBS Parkinson's Disease	51 Participants	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment Germany	16 Participants	—
Region of Enrollment Spain	7 Participants	—
Region of Enrollment Sweden	4 Participants	—
Region of Enrollment United States	15 Participants	—
Sex: Female, Male Female	22 Participants	—
Sex: Female, Male Male	52 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 71
other Total, other adverse events	2 / 71
serious Total, serious adverse events	1 / 71

Outcome results

Primary

Rate of MRI-related Adverse Events

Any adverse event that was included in the primary endpoint analysis, if it: 1. Was classified as being MRI-related (as determined by the CEC), occured during or after the MRI procedure, and cannot be attributed to any other cause; and 2. Was classified as being related to the device (implanted or external component) (as determined by the Investigator); and 3. Met the criteria for serious adverse event or was a non-serious adverse event that was the result of irrecoverable failure of therapy delivery or device communication.

Time frame: From MRI procedure through 1 month post-MRI procedure