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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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OSB Lead-SMART-MSP PAS


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General
Study Status Progress Adequate
Application Number P960040 S385/ PAS001
Date Current Protocol Accepted  
Study Name OSB Lead-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
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
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.



OSB Lead-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    
18 month report 10/31/2018    
two year report 05/02/2019    
three year report 05/01/2020    
Final Report 07/31/2020    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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