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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P080006 S068/ PAS001 |
| Date Original Protocol Accepted |
08/01/2014
|
| Date Current Protocol Accepted |
08/01/2014
|
| Study Name |
Post-Approval Study Registry
|
| Device Name |
ATTAIN PERFORMA MODEL 4298 LEFT VENTRICULAR LEAD
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The Attain Performa PAS is a non-randomized,
observational, world-wide study with prospective data collection. Data collection will begin at patient enrollment and will continue at six-month intervals through five years post-implant. Follow-up windows consistent with typical practice have been established and will be provided to sites to facilitate a robust data set and ensure reporting consistency. Attain Performa IDE patients are eligible to continue in the PAS upon market approval if they are followed at a participating PAS study site and are
consented.
|
| Study Population |
All patients who meet eligibility criteria and are implanted
with an Attain Performa lead will be included in analysis of the PAS objectives.
Inclusion criteria:
Patient or legally authorized representative provides written authorization and/or consent per institution
and geographical requirements
Patient has or is intended to receive or be treated with an eligible product
Patient within enrolment window relative to therapy initiation or meets criteria for retrospective enrollment
Exclusion criteria:
Patient who is, or is expected to be inaccessible for follow-up
Patient with exclusion criteria required by local law
Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
There are no comparison groups
|
| Sample Size |
A total of 1,778 Attain Performa leads will be enrolled in
the PAS. The study will be conducted at 150 study sites located in the United States (US), Canada, and ECA (Europe and Central Asia). Enrollment outside the United States (OUS) will be limited to no more than 50% of the overall sample size.
Enrollment of1778 Attain Performa leads results in 1050 leads followed for 5-years. This assumes a 10% per year attrition rate and provides a power of over 80% to test the primary objective. Sample size determinations must satisfy the primary objective analysis requirement and provide a reliable estimate of individual failure mode rates for the general population. The distribution of Attain Performa
lead-related complications can be expressed as binomial (n,
p=0.4%). Therefore, the probability of detecting a rare event can be calculated as a function of n.
|
| Key Study Endpoints |
Study Endpoints Primary Endpoints:
To demonstrate that the complication-free probability is greater than 92.5% at five years post-implant for the Attain Performa Model 4298 lead. For the purposes of the PAS, survival from Attain Performa lead-related complications will be based on acute and chronic complications as illustrated in Table below.
/ Undersensing
Table 4 Full Protocol for: Attain PerformaTM Left Ventricular Quadripolar Lead Post-
Approval Study Registry Analysis Plan, Version 2, Date July 2, 2014
Study Element Description
Secondary Endpoint:
¿ To summarize all Attain Performa lead-related ADEs
¿ To summarize analysis results from explanted and returned Attain Performa leads
Additional analysis will be to report on incidence of pacing threshold rise per the following:
¿ At implant, pacing thresholds for the programmed
LV pacing vector that are > 3.0 Volts at > 0.4 ms
¿ At 6-months, pacing thresholds for the programmed
LV pacing vector that are > 3.5 Volts at > 0.4 ms (6- month threshold values will be regarded as the baseline for chronic thresholds)
¿ At 12-months and all eventual follow-up visits, an observed threshold increase 1.5 Volts over the 6- month values, or an absolute value > 3.5 Volts at >
0.4 ms
|
| Follow-up Visits and Length of Follow-up |
5 years post-implant
Post-approval reports will be submitted to the FDA every six
months for the first two years after the first Attain Performa
PMA-S approval, then annually thereafter.
|
| Interim or Final Data Summary |
| Interim Results |
The overall complication free rate for across all leads at 60 months was 98.75% (95% CI: 97.85%, 99.27%).
|
| Actual Number of Patients Enrolled |
1900
|
| Actual Number of Sites Enrolled |
114
|
| Patient Follow-up Rate |
88.43%
|
| Study Strengths & Weaknesses |
The progress report was found to be adequate with sufficient follow-up rate and with a complication free rate which is above the approved performance goal (92.5%).
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