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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LESS VT NICM Post-Approval Study

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Study Status Ongoing
Application Number /
Requirement Number
P110016 S080/ PAS002
Date Original Protocol Accepted 02/24/2023
Date Current Protocol Accepted  
Study Name LESS VT NICM Post-Approval Study
Device Name FlexAbility™ Ablation Catheter, Sensor Enabled™
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives The goal of this post approval study is to confirm the safety and effectiveness of the study catheter for the treatment of
MMVT in the post-market space.
Study Population This clinical investigation will enroll subjects of all sexes who have recurrent, drug-refractory, sustained MMVT from non-ischemic origin. Patients must meet all general eligibility criteria and provide written informed consent prior to sites conducting any investigation-specific procedures not
considered standard of care.
Sample Size Approximately one hundred fifty (150) subjects will be enrolled in this clinical investigation at up to 25 sites in the United States for analysis of the primary endpoints. At least 50% of subjects will be greater than or equal to 65 years of age.
Key Study Endpoints The primary safety endpoint will be the rate of study device and/or Study Ablation Procedure-related SAEs through 12 months post Index Ablation Procedure. This endpoint will be descriptively evaluated at 12 months.
Only study device (FlexAbility SE)-related adverse events related to use during Study Ablation Procedures will be collected.
The primary effectiveness endpoint is a composite of 12-month freedom from VT recurrence, death, and cardiac transplantation. This endpoint will be descriptively evaluated at 12 months. VT recurrence is defined as:
Continuous VT for >30 seconds o If the subject has continuous VT throughout a 12-lead ECG recording, this will be considered sufficient documentation of recurrence unless there is evidence that the recorded arrhythmia is short-lived and less than 30 seconds.
VT requiring intervention for termination regardless of its duration
Repeat Ablation Procedure
Use of a non-study device for ablation to the ventricles or cardiac ablation by any method other than RF energy during a Study Ablation Procedure will be considered an effectiveness failure.
There are several descriptive endpoints. These endpoints will be summarized descriptively and no hypothesis tests will be performed.
The primary safety endpoint and primary effectiveness endpoint will be summarized separately for subjects <65 years of age and subjects greater than or equal to 65 years of age
12-month all-cause mortality
12-month freedom from VT
12-month freedom from cardiac transplantation
Study device- or Study Ablation Procedure- related SAEs through 7 days
Rate of Repeat Ablation Procedures
Follow-up Visits and Length of Follow-up Subjects will be followed for up to 12-months post-procedure
Interim or Final Data Summary
Actual Number of Patients Enrolled 7
Actual Number of Sites Enrolled 5
Patient Follow-up Rate Insufficient enrollment and duration of follow-up to determine follow-up rate.
Final Safety Findings Insufficient enrollment and duration of follow-up to draw safety conclusions.
Final Effect Findings Insufficient enrollment and duration of follow-up to draw effectiveness conclusions.

LESS VT NICM Post-Approval Study Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 06/14/2023 06/13/2023 On Time
1 year report 12/14/2023 12/12/2023 On Time
18 month report 06/13/2024    
2 year report 12/13/2024    
3 year report 12/13/2025    

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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