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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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SMART-MSP PAS


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General
Study Status Completed
Application Number P010012 S436/ PAS001
Date Current Protocol Accepted 11/17/2017
Study Name SMART-MSP PAS
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own Control
Analysis Type Analytical
Detailed Study Protocol Parameters
Study Design Description Evaluate the effectiveness of Boston Scientific (BSC)’s LV MSP (Left Ventricular MultiSite Pacing) feature in the Resonate family of CRT-D devices1 and confirm safety in a post approval study when used in accordance with its approved labeling.

Prospective, multi-center, single arm, post approval study to be conducted in the United States.
Study Population Description Subjects who are non-responders to conventional Biventricular (BiV) CRT-D therapy
Sample Size Primary Safety Endpoint:

The overall study sample size of 586 subjects is driven by the primary effectiveness endpoint. The sample size of 61 subjects is required to evaluate the Primary Safety Endpoint. Since a power calculation cannot be directly calculated for a one group Kaplan-Meier analysis, an exact test was used. A power calculation using a sample size of 61 subjects as the non-responders with the LV MSP on was calculated based on a one-sided exact test for a single binomial proportion, using SAS Version 9.4 with the following assumptions:
Performance goal = 90%
Expected LV MSP feature-related CFR rate between 6 and 12 Month Visit = 98%
Significance level = 5%
Power = 80%
Primary Effectiveness Endpoint:

The sample size of 110 subjects with paired CCS calculation from the 6 Month Visit through 12 Month Visit is required to evaluate the Primary Effectiveness Endpoint. For further details on overall sample size and attrition see Figure 12.3-1. The overall study sample size is
driven by the primary effectiveness endpoint. This sample size was calculated based on a one-sided exact test for a single binomial proportion, using SAS Version 9.4 with the following assumptions:
Performance goal = 5%
Expected performance = 15%
One-sided significance level = 5%
Power = 95%
Data Collection The primary safety endpoint for SMART-MSP is LV MSP feature-related complication-free rate
between the 6 Month Visit and the 12 Month Visit in non-responders with the LV MSP turned on for any duration and the primary effectiveness endpoint is Proportion of the LV MSP Group subjects with Improved Clinical Composite Score (CCS) from the 6 Month Visit through the 12 Month Visit.
Follow-up Visits and Length of Follow-up The length of follow-up is maximum of 12 months.

Subjects determined to be a responder at their 6 month visit will complete the study. Subjects in the non-responder group, including those subjects who have no LV MSP turned on, will complete the study at their 12 month visit.
Interim or Final Data Summary
Actual Number of Patients Enrolled 594 patients
Actual Number of Sites Enrolled 52 sites
Patient Follow-up Rate The mean months +/- SD of all enrolled subjects was 7.0 +/- 3.1.
Final Safety Findings The LV MSP feature related complication-free rate was 99.0% with a lower 95% confidence limit of 94.9%, which was higher than the performance goal of 90%.
Final Effect Findings The proportion of Non-Responder subjects with an improved CCS from 6-12 months was 51.3% with a lower 95% confidence limit of 41.4%, which was higher than the performance goal of 5%.
Study Strengths & Weaknesses The firm has fulfilled the conditions of approval by completing the study as planned. There are no safety concerns raised by this large study. Detailed review of the adverse events shows no specific adverse event types are increased over what we might see in this population. Overall, the MSP
approach shows a substantial minority of subjects benefitted.
Recommendations for Labeling Changes Yes, a labeling change is recommended. The study results are favorable, free of new safety signals and show a promising effectiveness signal. These results should be included in an update to the label.


SMART-MSP PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/31/2017 11/06/2017 Overdue/Received
one year report 05/02/2018 04/24/2018 On Time
18 month report 11/01/2018 11/01/2018 On Time
two year report 05/02/2019 05/02/2019 On Time
three year report 05/01/2020 05/05/2020 Overdue/Received
final report 05/01/2021 03/01/2021 On Time


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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