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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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PAS of HeartLight Endoscopic Ablation Sys


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General
Study Status Ongoing
Application Number /
Requirement Number		 P150026 / PAS001
Date Original Protocol Accepted 04/01/2016
Date Current Protocol Accepted 07/01/2020
Study Name PAS of HeartLight Endoscopic Ablation Sys
Device Name HEARTLIGHT ENDOSCOPIC ABLATION SYSTEM
Clinical Trial Number(s) NCT00958165 NCT01456000 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives The purpose of this study is to evaluate the long-term safety and effectiveness of the device in a commercial population and to clarify the safety profile of the device among females. This will be accomplished through a new enrollment prospective single-armed study.

Study Population 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 at up to 25 sites in the US, and a minimum 135 of those subjects will be female, will accommodate the hypothesis testing with 80% power and an alpha of 0.025 for each of the hypotheses.
Key Study Endpoints 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.
Interim or Final Data Summary
Actual Number of Patients Enrolled 103
Actual Number of Sites Enrolled 10
Final Safety Findings There have been no unanticipated adverse events. Since the last report, there have been 5 new events (total 38). The new events included a stroke (unrelated to both the device and procedure), phrenic nerve palsy not beyond blanking period, and 3 events during follow-up that were reported as unrelated to both the device and procedure.
Final Effect Findings Overall, acute success is 94.8%.


PAS of HeartLight Endoscopic Ablation Sys Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 09/30/2016 09/27/2016 On Time
1 year report 04/01/2017 03/31/2017 On Time
18 month report 09/30/2017 09/29/2017 On Time
2 year report 04/01/2018 03/30/2018 On Time
30 month report 10/30/2018 10/30/2018 On Time
3 year report 05/01/2019 05/01/2019 On Time
42 month report 11/01/2019 11/01/2019 On Time
4 year report 05/01/2020 05/01/2020 On Time
54 month report 11/01/2020 10/30/2020 On Time
5 year report 05/01/2021 04/30/2021 On Time
66 month report 11/01/2021 11/01/2021 On Time
6 year report 05/01/2022 04/29/2022 On Time
7 year report 05/01/2023 04/27/2023 On Time
8 year report 05/01/2024 04/30/2024 On Time
9 year report 05/01/2025    


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

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