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|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P110042 S077/ PAS001 |
| Date Original Protocol Accepted |
09/29/2017
|
| Date Current Protocol Accepted |
12/08/2023
|
| Study Name |
EMBLEM S-ICD Electrode Model 3501 PAS
|
| Device Name |
Model 3501 EMBLEM S-ICD subcutaneous Electrode
|
| General Study Protocol Parameters |
| Study Design |
Other Study Design
|
| Data Source |
External Registry
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
Child: 2-12 yrs,
Adolescent: 13-18 yrs,
Transit. Adolescent A (distinctively) : 18-21 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Primary analyses will use existing data sources from patients implanted with the EMBLEM S-ICD Electrode Model 3501 and represented in the following databases:
NCDR: ICD Registry;
LATITUDE NXT Patient Management System;
CMS Claims Database; and
National Death Index (linage to NCDR patients).
Each database is associated with a unique, independently-powered co-primary endpoint. Comparisons will be made to the predecessor EMBLEM S-ICD Electrode Model 3401. An unpowered secondary analysis will be performed using patients from Truven Marketscan Database (private insurance claims).
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| Study Population |
Patients will come from the US implant population with EMBLEM S-ICD Electrode Model 3501 whose data are captured in one of the databases utilized for this study.
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| Sample Size |
The primary analysis cohorts will consist of consecutive patients implanted with EMBLEM S-ICD Electrode Model 3501 identified in the following databases:
NCDR ICD Registry (N=2,100);
LATITUDE NXT Patient Management System (N=2,000);
CMS Claims Database (N=2,100); and
National Death Index linkage to NCDR patients (N=2,100).
The sample sizes given in the parentheses were calculated based on the provisional statistical assumptions given in Table 1-2 and will be updated based on PAS data for the EMBLEM S-ICD Electrode Model 3401. The sample sizes will be re-estimated and patients will be added if needed to ensure 90% power is maintained.
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| Key Study Endpoints |
Primary Endpoints:
NCDR: The first primary endpoint evaluates the rate of Model 3501 implant and periprocedural complications.
Remote Monitoring (LATITUDE NXT): The second primary endpoint evaluates the five-year rate of Model 3501 EMBLEM S-ICD Electrode integrity alerts.
Administrative Claims (CMS): The third primary endpoint evaluates the five-year rate of Model 3501 EMBLEM S-ICD Electrode complications requiring reoperation or hospitalization.
National Death Index: The fourth primary endpoint evaluates the five year rate of Model 3501 EMBLEM S-ICD Electrode patient deaths from any cause.
Secondary Endpoint:
Administrative Claims (Truven): The secondary endpoint evaluates the five-year rate of Model 3501 EMBLEM S-ICD Electrode complications requiring reoperation or hospitalization.
|
| Follow-up Visits and Length of Follow-up |
5 years
|
| Interim or Final Data Summary |
| Interim Results |
There are no major key findings at this time.
|
| Actual Number of Patients Enrolled |
NCDR: 11,228
LATITUDE: 27,981
CMS and NDI – Not available at time of report.
|
| Actual Number of Sites Enrolled |
N/A. Data from all US sites that contribute data to any of the databases used in the analysis.
|
| Patient Follow-up Rate |
Data will be collected during the course of routine device follow-up and patient care. No additional follow-ups or procedures are required.
Each primary analysis cohort will have a minimum of 5 years of follow-up.
As of 27 SEP-2023, there were N=27,981 Model 3501 electrodes found in the Latitude database of which 27,254 had follow up time available 21,930 patients had at least 6 months of follow-up, 18,418 had reached 12 months of follow-up, and 1,425 had reached 5 years of follow up.
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| Final Safety Findings |
No significant findings at time of report.
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| Final Effect Findings |
No significant findings at time of report.
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