Trial Outcomes & Findings for IPG Replacement Study (PREFERENCE-H) (NCT NCT02963259)

NCT ID: NCT02963259

Last Updated: 2024-07-08

Results Overview

Proportion of subjects who preferred constant current device over constant voltage, tested against a performance goal (PG) of 50.0% at the 3-month follow-up visit.

• Recruitment status: COMPLETED
• Target enrollment: 17 participants
• Primary outcome timeframe: 3 Months
• Results posted on: 2024-07-08

Participant Flow

The study enrolled a total of 17 subjects in 5 centers across Europe and United States between 29 March 2017 and 3 December 2018. Of the 17 enrolled subjects, 16 subjects were evaluated at the baseline visit and 12 completed the 3- and 12-month visit.

Of the total 17 participants enrolled, 5 were withdrawn for the reasons listed and only 16 completed the baseline.

Participant milestones

Measure	SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG System Subjects will be implanted with SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system: Implanted Medtronic® IPG will be explanted and replaced by a SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system
Overall Study STARTED	17
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG System Subjects will be implanted with SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system: Implanted Medtronic® IPG will be explanted and replaced by a SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system
Overall Study IPG Replacement not Done with Abbott Device	2
Overall Study Subject Participation Terminated by Investigator	1
Overall Study Death	1
Overall Study Subject Did Not Meet Inclusion/Exclusion Criteria	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG System n=16 Participants Subjects will be implanted with SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system: Implanted Medtronic® IPG will be explanted and replaced by a SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system
Age, Continuous	62.4 years STANDARD_DEVIATION 8.6 • n=16 Participants
Sex: Female, Male Female	7 Participants n=16 Participants
Sex: Female, Male Male	9 Participants n=16 Participants
Region of Enrollment United States	4 participants n=16 Participants
Region of Enrollment Italy	12 participants n=16 Participants
UPDRS Score UPDRS III on stimulation	23.6 units on a scale STANDARD_DEVIATION 16.1 • n=16 Participants
UPDRS Score UPDRS III off stimulation	39.8 units on a scale STANDARD_DEVIATION 18.24 • n=16 Participants

PRIMARY outcome

Timeframe: 3 Months

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

Proportion of subjects who preferred constant current device over constant voltage, tested against a performance goal (PG) of 50.0% at the 3-month follow-up visit.

Outcome measures

Measure	SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG System n=12 Participants Subjects will be implanted with SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system: Implanted Medtronic® IPG will be explanted and replaced by a SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system
The Percentage of Subjects Who Indicate Preference on Constant Current Over Constant Voltage at the 3 Month Follow-up Visit.	4 participants

SECONDARY outcome

Timeframe: 12 months after IPG replacement

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

Total number of safety events related to battery replacement surgical procedures for hybrid systems divided by total follow-up duration from IPG replacement visit to either 12M visit or withdrawal visit (patient-years).

Outcome measures

Measure	SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG System n=12 Participants Subjects will be implanted with SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system: Implanted Medtronic® IPG will be explanted and replaced by a SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system
Number of Events Per Patient-year of Follow-up	0 events per patient-year

SECONDARY outcome

Timeframe: 12 months after IPG replacement

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

Number of subjects who underwent IPG replacement and encountered safety events related to battery replacement surgical procedure for hybrid system divided by total subjects who underwent IPG replacement.

Outcome measures

Measure	SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG System n=13 Participants Subjects will be implanted with SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system: Implanted Medtronic® IPG will be explanted and replaced by a SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system
Incidence Rate	0 subjects

Adverse Events

SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG System

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Measure	SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG System n=17 participants at risk Subjects will be implanted with SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system: Implanted Medtronic® IPG will be explanted and replaced by a SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Cancer	5.9% 1/17 • 12 months

Other adverse events

Measure	SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG System n=17 participants at risk Subjects will be implanted with SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system: Implanted Medtronic® IPG will be explanted and replaced by a SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system
Product Issues High Impedance in Contact	5.9% 1/17 • 12 months
Nervous system disorders Worsening of Motor/Parkinson's Disease Symptoms - Akinesia	5.9% 1/17 • 12 months

Additional Information

Erika Ross

Abbott

Phone: +19725268207

Email: Erika.ross@abbott.com

Results disclosure agreements

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