f Post-Approval Studies (PAS) Database
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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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CF HeartLight PAS

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Study Status Progress Adequate
Application Number /
Requirement Number
P150026 S002/ PAS001
Date Original Protocol Accepted 05/02/2018
Date Current Protocol Accepted 07/01/2020
Study Name CF HeartLight PAS
Device Name Heart Light Catheter with Excalibur Balloon
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 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 Study subjects will be clinically eligible for treatment of paroxysmal atrial fibrillation with the HeartLight device.

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.

All safety, effectiveness, and operator training results will also be stratified by version of the HeartLight Endoscopic Ablation System (i.e. with or without Excalibur Catheter) as an additional descriptive analysis.
Follow-up Visits and Length of Follow-up Study subjects will be followed for 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
Interim Results 14.0% serious adverse event rate (40.7% total adverse event rate).
95.6% overall acute success rate.
Actual Number of Patients Enrolled 91
Actual Number of Sites Enrolled 10
Patient Follow-up Rate 98% at 12 months
Study Strengths & Weaknesses Subject enrollment increasing, number of study sites increasing.

CF HeartLight PAS Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 10/31/2018 10/30/2018 On Time
1 year report 05/02/2019 05/01/2019 On Time
18 month report 11/01/2019 11/01/2019 On Time
2 year report 05/01/2020 05/01/2020 On Time
30 month report 11/01/2020 10/30/2020 On Time
3 year report 05/01/2021 04/30/2021 On Time
42 month report 11/01/2021 11/01/2021 On Time
4 year report 05/01/2022 04/29/2022 On Time
5 year report 05/01/2023 04/27/2023 On Time
6 year report 05/01/2024    

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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