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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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HeartLight X3 PAS


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General
Study Status Progress Adequate
Application Number P150026 S008/ PAS001
Date Current Protocol Accepted  
Study Name HeartLight X3 PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Detailed Study Protocol Parameters
Study Design Description 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 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 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.
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


HeartLight X3 PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 11/01/2020 10/30/2020 On Time
one year report 05/01/2021 04/30/2021 On Time
two year report 05/01/2022    


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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