Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infinity DBS System with MR Conditional labelling | The Infinity DBS system with MR Conditional labelling includes a primary cell implantable pulse generator designed to deliver low-intensity electrical pulses to targeted structures in the brain. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infinity DBS System with MR Conditional labelling | Device | Patients implanted with the Infinity DBS system with MR Conditional labeling |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of MRI-related Adverse Events | Any adverse event that was included in the primary endpoint analysis, if it:
| From MRI procedure through 1 month post-MRI procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Successful MRI Mode 'Turn on/Off' Functionality of the MRI Mode | 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. | Immediately after the MRI scan |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
This clinical investigation will enroll subjects with levodopa-responsive Parkinson's disease, primary or secondary dystonia, or disabling tremor, and have been, or will be, implanted with the Infinity DBS system with MR Conditional labeling.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Binith Cheeran | Abbott Medical Devices Neuromodulation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center Tucson Campus | Tucson | Arizona | 85724 | United States | ||
| University of Colorado Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Infinity DBS System With MR Conditional Labeling | Patients implanted with the Infinity DBS system with MR Conditional labeling |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 16, 2019 | Jun 14, 2023 |
Not provided
Not provided
Not provided
Not provided
| Rate of Successful 'Turn on/Off' Functionality for the Stimulation |
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. |
| Immediately after the MRI scan |
| Rate of Successful Adjustments to the Stimulation Amplitude | 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. | Immediately after the MRI scan |
| Rate of Successful Interrogation and Download of the IPG Parameters | 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. | Immediately after the MRI scan |
| Rate of Successful Ability to Obtain Lead Impedance Measurements | 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. | Immediately after the MRI scan |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Neurosurgery One | Littleton | Colorado | 80122 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Willis-Knighton Medical Center | Shreveport | Louisiana | 71103 | United States |
| Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08901 | United States |
| Wright State University & Premier Health | Fairborn | Ohio | 45324 | United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | United States |
| Inland Northwest Research | Spokane | Washington | 99202 | United States |
| CHU Gabriel Montpied | Clermont-Ferrand | Auverg N | 63003 | France |
| Universitäts Klinikum Tübingen | Tübingen | Bad-wur | 72076 | Germany |
| Medizinische Einrichtungen der Universität Düsseldorf | Düsseldorf | N. RHIN | 40225 | Germany |
| Universitatsmedizin der Johannes Gutenberg-Universität Mainz | Mainz | Rhinela | 55131 | Germany |
| Hospital Universitario de la Princesa | Madrid | 28006 | Spain |
| Universitetsjukhuset I Lund | Lund | Skåne County | 22185 | Sweden |
| Akademiska sjukhuset | Uppsala | Uppland | 75185 | Sweden |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Infinity DBS System With MR Conditional Labeling | Patients implanted with the Infinity DBS system with MR Conditional labeling |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | 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 | Count of Participants | Participants |
| ||||||||||||||||||
| Number of participants with Primary Indication for DBS | Count of Participants | Participants |
|
| 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 | Rate of MRI-related Adverse Events | Any adverse event that was included in the primary endpoint analysis, if it:
| The number of participants analyzed includes subjects who were available at that time of analysis. | Posted | Number | Percentage of participants | From MRI procedure through 1 month post-MRI procedure |
|
|
| ||||||||||||||||||||||||||
| Secondary | Rate of Successful MRI Mode 'Turn on/Off' Functionality of the MRI Mode | 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. | The number of participants analyzed includes subjects who were available at that time of analysis. | Posted | Number | Percentage of participants | Immediately after the MRI scan |
|
| |||||||||||||||||||||||||||
| Secondary | Rate of Successful 'Turn on/Off' Functionality for the Stimulation | 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. | The number of participants analyzed includes subjects who were available at that time of analysis. | Posted | Number | percentage of participants | Immediately after the MRI scan |
|
| |||||||||||||||||||||||||||
| Secondary | Rate of Successful Adjustments to the Stimulation Amplitude | 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. | The number of participants analyzed includes subjects who were available at that time of analysis. | Posted | Number | Percentage of participants | Immediately after the MRI scan |
|
| |||||||||||||||||||||||||||
| Secondary | Rate of Successful Interrogation and Download of the IPG Parameters | 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. | The number of participants analyzed includes subjects who were available at that time of analysis. | Posted | Number | Percentage of participants | Immediately after the MRI scan |
|
| |||||||||||||||||||||||||||
| Secondary | Rate of Successful Ability to Obtain Lead Impedance Measurements | 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. | The number of participants analyzed includes subjects who were available at that time of analysis. | Posted | Number | Percentage of participants | Immediately after the MRI scan |
|
|
1 month
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Infinity DBS System With MR Conditional Labeling | Patients implanted with the Infinity DBS system with MR Conditional labeling | 0 | 71 | 1 | 71 | 2 | 71 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | [Not specified] | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Misplaced Lead | Injury, poisoning and procedural complications | [Not specified] | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tucker Tomlinson | Abbott | +1/ 972 526 9646 | tucker.tomlinson@abbott.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 18, 2020 | Jun 14, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D010300 | Parkinson Disease |
| D020329 | Essential Tremor |
| D014202 | Tremor |
| D004421 | Dystonia |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
|
| Germany |
|
|
| Spain |
|
|
|
|
| Parkinson's Disease |
|
|
|
|
|
|
|