NCT03884231

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

Completed Results posted Last updated 20 November 2024

What this trial tests

trial testing Infinity DBS System with MR Conditional labelling in Movement Disorders in 74 participants. Completed in 20 August 2021.

Timeline

10 April 2019

Primary endpoint
22 July 2021

20 August 2021

Quick facts

Lead sponsor	Abbott Medical Devices
Status	Completed
Study type	OBSERVATIONAL
Enrollment	74
Start date	10 April 2019
Primary completion	22 July 2021
Estimated completion	20 August 2021
Sites	16 locations across France, Sweden, Germany, United States, Spain

Drugs / interventions tested

• Infinity DBS System with MR Conditional labelling

Conditions studied

• Movement Disorders — all drugs for Movement Disorders →
• Parkinson Disease — all drugs for Parkinson Disease →
• Essential Tremor — all drugs for Essential Tremor →
• Tremor — all drugs for Tremor →

Sponsor

Abbott Medical Devices — full company profile →

Who can join

Eligibility, any sex, with Movement Disorders or Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Rate of MRI-related Adverse Events Primary · 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.

Group	Value	95% CI
Infinity DBS System With MR Conditional Labeling	0

Rate of Successful MRI Mode 'Turn on/Off' Functionality of the MRI Mode Secondary · 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.

Group	Value	95% CI
Infinity DBS System With MR Conditional Labelling (Full System Configuration)	100

Rate of Successful 'Turn on/Off' Functionality for the Stimulation Secondary · 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.

Group	Value	95% CI
Infinity DBS System With MR Conditional Labelling (Full System Configuration)	100

Rate of Successful Adjustments to the Stimulation Amplitude Secondary · 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.

Group	Value	95% CI
Infinity DBS System With MR Conditional Labelling (Full System Configuration)	100

Rate of Successful Interrogation and Download of the IPG Parameters Secondary · 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.

Group	Value	95% CI
Infinity DBS System With MR Conditional Labelling (Full System Configuration)	100

Rate of Successful Ability to Obtain Lead Impedance Measurements Secondary · 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.

Group	Value	95% CI
Infinity DBS System With MR Conditional Labelling (Full System Configuration)	100

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 month. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Infinity DBS System With MR Conditional Labeling

Serious: 1/71 (1%)

Deaths: 0/71

Serious adverse events (1 terms)

Reaction	System	Infinity DBS System With M…
Pulmonary Edema	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (1 terms — click to expand)

Reaction	System	Infinity DBS System With M…
Misplaced Lead	Injury, poisoning and procedural complications	—

Most-reported serious reactions: Pulmonary Edema.

Data from ClinicalTrials.gov NCT03884231 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.