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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P080006 S129/ PAS001 |
| Date Original Protocol Accepted |
04/10/2019
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| Date Current Protocol Accepted |
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| Study Name |
Attain Stability Quad PAS
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| Device Name |
Attain Stability Quad MRI SureScan Lead
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
Sponsor Registry
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| Comparison Group |
Concurrent & Historical Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The Medtronic Attain Stability Quad (ASQ) LV Lead Post-Approval Study (PAS) is a nonrandomized, multi-site, world-wide clinical study of implanted commercially available Model 4798 leads. The study is conducted in the US, Canada, Europe (and Asia). All enrolled patients were implanted with a Model 4798 LV Lead and all data is collected prospectively.
Data will be collected through Medtronic’s Post Market Surveillance platform and through leveraging extant data including potential use of administrative claims, electronic health records, available registries, and remote monitoring.
The study requires a minimum of 1000 leads enolled to satisfy both the primary objective analysis sample size requirement and to estimate individual failure modes at five year post implant for the general population. Attain Stability Quad ISE patients are eligible to continue in the PAS upon market approval is followed at a participating Product Surveillance Registry (PSR) study site and are consented.
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| Study Population |
Patients included in the Model 4798 lead Post Approval Study, were consented and implanted with a Model 4798 LV Lead
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| Sample Size |
The PAS plans to prospectively enroll 1000 subjects through the PSR
Sample Size Justification
Power 0.864
a 0.05 (two-sided)
Success Rate, investigational 95.5%
PG 92.5%
Attrition 12% per year
N 1000
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| Key Study Endpoints |
Primary Objective
To demonstrate that the complication-free probability is greater than 92.5% at five years post-implant for Attain Stability Quad LV leads
Primary objective analysis includes all complications related to lead hardware or design failure as pre-specified in the Attain Stability Quad Post Approval Study, Analysis Plan (Version 1, 12 Oct 2018) and base protocol of the Product Surveillance Registry (PSR) (Version 6, 7 March 2016).
Secondary Objective
To summarize all lead related adverse events or Adverse Device Effects (ADEs)
To summarize analysis results from explanted and returned Attain Stability Quad leads
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| Follow-up Visits and Length of Follow-up |
All enrolled patients will be followed for 5 years
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