|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P110042 S058/ PAS001 |
| Study Name |
EMBLEM MRI S-ICD Pt Mgmt System Surv PAS
|
| Device Name |
SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Active Surveillance
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Non-randomized, observational surveillance effort using a remote data collection database to identify spontaneous episodes of VF
following possible clinical MRI exposure. Identified episodes will be used to assess sensing and detection via time-to-therapy. All data
will be collected via Boston Scientific’s Latitude NXT Patient Management System and de-identified for analysis.
|
| Study Population |
All Boston Scientific S-ICD systems that have been placed into MRI Protection Mode and transmit data to the Latitude NXT Patient
Management System. Subjects to be included will meet two criteria:
Possible MRI exposure (as indicated by MRI Protection Mode having been enabled), and
At least one documented spontaneous treated episode of VF subsequent to possible MRI exposure
|
| Sample Size |
25 subjects will contribute to this data analysis.
Assuming a time to therapy of 20.0 seconds (S),1 a sample size of 25 episodes will produce a 95% confidence interval of [18.0, 22.0] S.
The following assumptions were used to define the scope and duration:
US sales projections indicate that an estimated 8,600 BSC SICD
Systems will be implanted annually for the next 5 years.
An estimated 70% of S-ICDs in the US will enroll and regularly transmit device data through the Latitude NXT Patient Management System.
The annual incidence MRI scans in ICD patients is approximately 10%
Based on episode data from the S-ICD Clinical Investigation, the annual incidence of VF is approximately 1-2% of patients per year.
Per the above assumptions, it will take approximately 5 years to complete the project.
|
| Key Study Endpoints |
Primary Endpoints:
The mean, median and standard deviation of time to therapy will be assessed for the first appropriately treated spontaneous episode of
VF following placement into MRI Protection Mode.
The time to therapy is defined as the interval starting when the rate of the VF is greater or equal to the lowest programmed zone
(Conditional Zone) and measured until the start of the shock marker.
Additional Observational Endpoints:
Number of devices programmed to MRI Protection Mode
Number / type of spontaneous episodes of VT/VF following placement in MRI Protection Mode
Last shock impedance for episodes of VT/VF that occur subsequent to placement in MRI Protection Mode
In the event that the calculated time to therapy exceeds 30 seconds, additional treated episodes from the same device prior to the MRI
will be identified. This will allow within-patient time-to-therapy comparisons before and after the device is programmed into MRI
Protection Mode. Additionally, the clinic and enrolling physician will be queried in order to identify the patient and provide an
opportunity to consent to providing additional data, including:
Details around the programming of MRI Protection Mode
Details of the MRI
Other pertinent medical history information that might explain the long time to therapy
|
| Follow-up Visits and Length of Follow-up |
5 years post-approval
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
34 subjects included in the endpoint analysis
|
| Actual Number of Sites Enrolled |
0 sites – study was performed using data collected from Latitude NXT Patient Management Systems transmissions
|
| Patient Follow-up Rate |
No patient follow-up required by study design due to data collection method using home monitor data.
|
| Final Safety Findings |
The time to therapy was assessed for the first appropriately treated spontaneous episode of ventricular fibrillation (VF) following placement into MRI Protection Mode.
|
| Final Effect Findings |
N/A study just had the endpoint listed above
|
| Study Strengths & Weaknesses |
Study used real-world evidence sources which eliminated the need for the use of sites for data collection. The study design allowed the study to be conducted faster and with more patients than planned (25 planned). The weakness of the study is that it was reliant on home monitor data and did not have the full follow-up with in-person patient visits to identify potential other signals unrelated to the time to therapy endpoint.
|
| Recommendations for Labeling Changes |
No labeling change is recommended as the performance is in line with the performance observed during the premarket study.
|
