Trial Outcomes & Findings for A Post-Market Study Evaluating the Safety of Infinity DBS System With MR Conditional Labeling (NCT NCT03884231)

NCT ID: NCT03884231

Last Updated: 2024-11-20

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 74 participants
• Primary outcome timeframe: From MRI procedure through 1 month post-MRI procedure
• Results posted on: 2024-11-20

Participant Flow

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.

Participant milestones

Measure	Infinity DBS System With MR Conditional Labeling Patients implanted with the Infinity DBS system with MR Conditional labeling
Overall Study STARTED	74
Overall Study COMPLETED	71
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Infinity DBS System With MR Conditional Labeling Patients implanted with the Infinity DBS system with MR Conditional labeling
Overall Study Subject Did Not Meet Inclusion/Exclusion Criteria	1
Overall Study Subject Withdrew Consent	1
Overall Study MRI Scan Not Performed	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Infinity DBS System With MR Conditional Labeling n=74 Participants Patients implanted with the Infinity DBS system with MR Conditional labeling
Age, Continuous	63.4 years STANDARD_DEVIATION 9.8 • n=74 Participants
Sex: Female, Male Female	22 Participants n=74 Participants
Sex: Female, Male Male	52 Participants n=74 Participants
Region of Enrollment Sweden	4 Participants n=74 Participants
Region of Enrollment United States	15 Participants n=74 Participants
Region of Enrollment Germany	16 Participants n=74 Participants
Region of Enrollment Spain	7 Participants n=74 Participants
Number of participants with Primary Indication for DBS Dystonia	1 Participants n=74 Participants
Number of participants with Primary Indication for DBS Essential Tremor	22 Participants n=74 Participants
Number of participants with Primary Indication for DBS Parkinson's Disease	51 Participants n=74 Participants

PRIMARY outcome

Timeframe: From MRI procedure through 1 month post-MRI procedure

Population: The number of participants analyzed includes subjects who were available at that time of analysis.

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.

Outcome measures

Measure	Infinity DBS System With MR Conditional Labeling n=71 Participants Patients implanted with the Infinity DBS system with MR Conditional labeling
Rate of MRI-related Adverse Events	0 Percentage of participants

SECONDARY outcome

Timeframe: Immediately after the MRI scan

Population: The number of participants analyzed includes subjects who were available at that time of analysis.

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.

Outcome measures

Measure	Infinity DBS System With MR Conditional Labeling n=42 Participants Patients implanted with the Infinity DBS system with MR Conditional labeling
Rate of Successful MRI Mode 'Turn on/Off' Functionality of the MRI Mode	100 Percentage of participants

SECONDARY outcome

Timeframe: Immediately after the MRI scan

Population: The number of participants analyzed includes subjects who were available at that time of analysis.

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.

Outcome measures

Measure	Infinity DBS System With MR Conditional Labeling n=34 Participants Patients implanted with the Infinity DBS system with MR Conditional labeling
Rate of Successful 'Turn on/Off' Functionality for the Stimulation	100 percentage of participants

SECONDARY outcome

Timeframe: Immediately after the MRI scan

Population: The number of participants analyzed includes subjects who were available at that time of analysis.

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.

Outcome measures

Measure	Infinity DBS System With MR Conditional Labeling n=34 Participants Patients implanted with the Infinity DBS system with MR Conditional labeling
Rate of Successful Adjustments to the Stimulation Amplitude	100 Percentage of participants

SECONDARY outcome

Timeframe: Immediately after the MRI scan

Population: The number of participants analyzed includes subjects who were available at that time of analysis.

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.

Outcome measures

Measure	Infinity DBS System With MR Conditional Labeling n=33 Participants Patients implanted with the Infinity DBS system with MR Conditional labeling
Rate of Successful Interrogation and Download of the IPG Parameters	100 Percentage of participants

SECONDARY outcome

Timeframe: Immediately after the MRI scan

Population: The number of participants analyzed includes subjects who were available at that time of analysis.

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.

Outcome measures

Measure	Infinity DBS System With MR Conditional Labeling n=33 Participants Patients implanted with the Infinity DBS system with MR Conditional labeling
Rate of Successful Ability to Obtain Lead Impedance Measurements	100 Percentage of participants

Adverse Events

Infinity DBS System With MR Conditional Labeling

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Infinity DBS System With MR Conditional Labeling n=71 participants at risk Patients implanted with the Infinity DBS system with MR Conditional labeling
Respiratory, thoracic and mediastinal disorders Pulmonary Edema	1.4% 1/71 • 1 month

Other adverse events

Measure	Infinity DBS System With MR Conditional Labeling n=71 participants at risk Patients implanted with the Infinity DBS system with MR Conditional labeling
Injury, poisoning and procedural complications Misplaced Lead	2.8% 2/71 • 1 month

Additional Information

Tucker Tomlinson

Abbott

Phone: +1/ 972 526 9646

Email: tucker.tomlinson@abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place