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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P910073 S145/ PAS001 |
| Date Original Protocol Accepted |
05/04/2018
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| Date Current Protocol Accepted |
07/07/2020
|
| Study Name |
MOUNTAIN PAS
|
| Device Name |
Reliance 4- Front Lead Family and Suture Sleeve Accessory
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| Clinical Trial Number(s) |
NCT02071173
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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 |
| Interim Results |
Safety Results
The observed primary event-free rate at 5 years equaled 99.5% with a lower confidence limit of 99.2%. In addition, the shape of curve indicates no signal of accelerating risk of failure (Weibull shape [95% CI] = 0.57 [0.41, 0.80]). No secondary or tertiary analyses were triggered due to the results of this analysis.
There were 5097 RELIANCE 4-FRONT leads in single-chamber systems that contributed to the sensitivity analysis. The observed primary event-free rate at 5 years equaled 97.7% with a lower confidence limit of 97.0% (Figure 7-6). There was no signal of accelerating risk failure. No secondary or tertiary analyses were triggered due to the results of this analysis.
Effectiveness Results
N/A
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| Actual Number of Patients Enrolled |
CMS Fee-for-Service patients with RELIANCE 4-FRONT leads: N = 10,678
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 |
The 10,678 RELIANCE 4-FRONT leads with fee-for-service coverage at time of implant have been followed for a median of 39.2 months. Chronic follow-up: 10,298
No concern for the follow-up sample size. Since this study uses RWE, there is no calculated follow-up rate.
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