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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-PAS of HeartLight Endoscopic Ablation Sys


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General
Study Status Progress Adequate
Application Number P150026 / PAS001
Study Name OSB Lead-PAS of HeartLight Endoscopic Ablation Sys
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a new enrollment prospective single-arm study.
Study Population Description The study population will be subjects clinically eligible for the treatment of paroxysmal atrial fibrillation with the HeartLight Endoscopic Ablation System.
Sample Size 250 subjects will be enrolled, and a minimum 135 of those subjects will be female.

If 135 female participants are treated, the sample size will be sufficient to provide 80% power to demonstrate that the primary safety endpoint, occurrence of Primary Adverse Events (PAEs) for females is less than 14% using a single sample test of a proportion against the performance goal with a one-sided type 1 error rate (alpha) of 0.025, when the expected PAE is 6%. This hypothesis will be tested when the full cohort has reached one year of follow-up, and the sample size accounts for an estimated yearly 10-15% loss to follow-up.

A sample size of 191 participants is estimated based on the Primary Effectiveness Endpoint hypothesis using a single sample test of a proportion against the performance goal of 55%. The expected Primary Effectiveness Endpoint rate in the HeartLight treated participants is 65%.

Assuming up to 15% lost to follow-up at the 1 year primary endpoint assessment, 225 treated participants provides 80% power to demonstrate that the Primary Effectiveness Endpoint rate is above the pre-established performance goal of 55% with a one-sided type I error rate of 0.025.
Data Collection The primary effectiveness endpoint will be freedom from symptomatic Atrial Fibrillation at one-year, and will be compared to a performance goal of 55% of subjects free from symptomatic AF at one year.

The primary safety outcome for the entire cohort will be the percentage of subjects experiencing a Primary Adverse Event by one-year of follow-up, and will be compared to a performance goal of PAE rate of 14% at one year.

The same safety outcome will be assessed for females with the same performance goal.

Longer term (three year) safety and effectiveness will be assessed as secondary outcomes.

The long-term effect of operator experience will also be assessed as a secondary outcome.

If there are gender differences in safety outcomes, the factors contributing to these differences will be evaluated as secondary outcomes.
Follow-up Visits and Length of Follow-up Three years

All subjects will undergo clinical follow-up pre-discharge, at 30 days, 90 days, 12 months, 24 months, and 36 months.


OSB Lead-PAS of HeartLight Endoscopic Ablation Sys Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 09/30/2016 09/27/2016 On Time
one year report 04/01/2017 03/31/2017 On Time
18 month report 09/30/2017 09/29/2017 On Time
two year report 04/01/2018    
three year report 04/01/2019    
four year report 03/31/2020    
five year report 03/31/2021    


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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