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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P010012 S398/ PAS001 |
| Date Original Protocol Accepted |
02/22/2016
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| Date Current Protocol Accepted |
07/07/2020
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| Study Name |
MOUNTAIN PAS
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| Device Name |
ACUITY X4 STRAIGHT (4671,4672), SPIRAL S (4674,4675), SPIRAL L (4677,4678) LEADS; SUTURELESS SLEEVE & FLUSHING TOOL/WIRE
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| General Study Protocol Parameters |
| Study Design |
Comprehensive/Linked/RegistryBased Surveillance
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| Data Source |
Admin Database
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| Comparison Group |
Historical Control
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| Analysis Type |
Analytical
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The purpose of the MOUNTAIN PAS program is to provide a sustainable mechanism for the collection of data to assess the
short and long term performance of Boston Scientific BSC pacing and defibrillation leads. The data sources used to evaluate the ACUITY X4 lead include four existing Real-World Data (RWD) databases and one clinical trial database.
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| Study Population |
All patients added to each database (CMS, Device Tracking, LATITUDE, Complaints database) during the evaluation period will be included in the analyses as specified.
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| Sample Size |
Data from all US centers that contribute data to any of the databases will be used in the analysis.
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| Key Study Endpoints |
The sponsor states that the short-term safety and short- and long-term effectiveness objectives have already been fulfilled through evaluation of clinical trial data. The long-term safety objective has yet to be fulfilled and will be assessed by the Primary Safety Endpoint, Sensitivity Analysis and other analysis specified.
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| Follow-up Visits and Length of Follow-up |
Data will be collected during routine device follow-up and patient care. No additional follow-ups or procedures are required.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
ACUITY X4: CMS Fee-for-Service patients with ACUITY X4 leads (N = 34,741)
RELIANCE 4-FRONT: CMS Fee-for-Service patients with RELIANCE 4-FRONT leads (N = 10,677)
There is no concern for the sample size since this sample size exceeds the minimum 1000 leads required
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| Actual Number of Sites Enrolled |
N/A; This study uses RWD
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| Patient Follow-up Rate |
ACUITY X4: The 34,741 ACUITY X4 leads with fee-for-service coverage at time of implant have been followed for a median of 28.0 months. Chronic follow-up: 33,834
RELIANCE 4-FRONT: The 10,402 RELIANCE 4-FRONT leads with fee-for-service coverage at time of implant have been followed for a median of 20.3 months. Chronic Follow-up: 10,294
No concern for the follow-up sample size. Since this study uses RWE, there is no calculated follow-up rate.
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| Final Safety Findings |
ACUITY X4: The observed primary event-free rate at 5 years equaled 99.5% with a lower confidence limit of 99.4%. There was no signal of accelerating risk of failure. No secondary or tertiary analyses were triggered due to the results of this analysis. The majority of ACUITY X4 Primary Endpoint events occurred in the Malfunction / Breakdown / Mechanical category, with an occurrence rate of < 0.3%. The overall
complication-free rate is 97.7% at five years with a lower confidence limit of 97.5%.
RELIANCE 4-FRONT: The observed primary event-free rate at 5 years equaled 99.6% with a lower confidence limit of 99.0%. There was no signal of accelerating risk of failure. No secondary or tertiary analyses were triggered due to the results of this analysis.
There were 5096 RELIANCE 4-FRONT leads in single-chamber systems that contributed to the analysis of the sensitivity analysis. The observed primary event-free rate at 5 years equaled 98.2% with a lower confidence limit of 97.3%. There was no signal of accelerating risk of failure. No secondary or tertiary analyses were triggered due to the results of this analysis. The sponsor states that the rate of occurence for each diagnosis code category could not be presented due to cell suppression restrictions. All categories had occurrence rates < 0.2%.
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| Final Effect Findings |
N/A
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| Study Strengths & Weaknesses |
The study progressed as expected and the sponsor met their endpoints.
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| Recommendations for Labeling Changes |
You have provided a report of the methods, planned analyses and outcomes from the Real World Evidence (RWE) data examination satisfying the Conditions of Approval Studies for ACUITY X4 and RELIANCE 4-FRONT leads. FDA review believes your outcomes are supportive of continued market approval and update of the labeling.
FDA also asks that you consider adding the following text and flow charts to your report to help practicing physicians understand the methods and limitations inherent in a RWE approach to showing continued reliability of these leads:
1) Please consider adding a flow chart and plain language text to explain how the most important primary endpoint outcomes related to reliability (for example and not limited to insulation break and electrode conductor fracture) are intended to be detected at the level of detection in each database according to your chosen RWE method. (In other words: What data must be found in each of the linked databases in order to adjudicate that a lead failure is detected?
2) Please add a limitations section explaining any manner in which detection of primary endpoint outcome adverse events may not occur, leading to a falsely normal lead performance adjudication
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