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This post-marketing evaluation has been designed to consistently investigate the subject's preference when switching from a Medtronic® constant voltage or constant current device to a St Jude Medical Infinity™ or St Jude Medical Brio™ constant current system. As electrodes will not be re-positioned, differences in subject's preference are to be explained by the difference in shape of the delivered pulse or waveform between the two systems.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system | Device | Implanted Medtronic® IPG will be explanted and replaced by a SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Subjects Who Indicate Preference on Constant Current Over Constant Voltage at the 3 Month Follow-up Visit. | 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. | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Events Per Patient-year of Follow-up | 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). | 12 months after IPG replacement |
| Incidence Rate |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who have a diagnosis matching the approved indication and are being considered for an IPG replacement comprise the target population of this study. All subjects who meet the inclusion and none of the exclusion criteria and have signed an Ethics Committee (EC) or Institutional Review Board (IRB) approved informed consent will be considered enrolled in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Edward Karst | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Hospital of Miami | Kendall | Florida | 33176 | United States | ||
| Neuroscience Consultants |
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Of the total 17 participants enrolled, 5 were withdrawn for the reasons listed and only 16 completed the baseline.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Percentage of Subjects Who Indicate Preference on Constant Current Over Constant Voltage at the 3 Month Follow-up Visit. | 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. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Number | participants | 3 Months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| High Impedance in Contact | Product Issues | MedDRA 11.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erika Ross | Abbott | +19725268207 | Erika.ross@abbott.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 10, 2016 | Oct 27, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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. |
| 12 months after IPG replacement |
| Miami |
| Florida |
| 33176 |
| United States |
| Albany Medical College at Albany Medical Ctr | Albany | New York | 12208 | United States |
| Praxis Dr. Oehlwein | Gera | Germany |
| Klinik am Tharandter Wald | Halsbrücke | Germany |
| Universitätsklinikum Leipzig AÖR | Leipzig | 04103 | Germany |
| Az.Osp. Universitaria Ferrara | Ferrara | Cona | 44124 | Italy |
| Fondazione "Ospedale San Camillo" I.R.C.C.S | Padua | Veneto | Italy |
| Ospedale Generale Regionale F. Miulli | Acquaviva delle Fonti | Italy |
| Ospedale dell'Angelo | Mestre | Italy |
| IRCCS Istituto Ortopedico Galeazzi | Milan | Italy |
| Fondazione Istituto Neurologico Nazionale C. Mondino | Pavia | Italy |
| Policlinico Universitario A. Gemelli | Roma | Italy |
| Azienda Ospedaliero-Universitaria S Maria della Misericordia | Udine | Italy |
| Subject Did Not Meet Inclusion/Exclusion Criteria |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| UPDRS Score | The UPDRS score collected at baseline is relevant because it presents patient's baseline motor severity. The modified UPDRS retains the four-scale structure with a reorganization of the various subscales. Score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Number of Events Per Patient-year of Follow-up | 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). | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Number | events per patient-year | 12 months after IPG replacement |
|
|
|
| Secondary | Incidence Rate | 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. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Number | subjects | 12 months after IPG replacement |
|
|
|
| 1 |
| 17 |
| 1 |
| 17 |
| 1 |
| 17 |
| Worsening of Motor/Parkinson's Disease Symptoms - Akinesia | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |