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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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RWU of LOTUS Edge Valve System


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General
Study Status Study Pending
Application Number P180029 / PAS002
Date Current Protocol Accepted  
Study Name RWU of LOTUS Edge Valve System
General Study Protocol Parameters
Study Design Comprehensive/Linked/RegistryBased Surveillance
Data Source External Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description To monitor device performance and assess safety and effectiveness outcomes associated with use of the LOTUS Edge™ Valve System (LOTUS Edge) for transcatheter aortic valve replacement (TAVR) in routine clinical practice using data collected in the Society of Thoracic Surgeons/American College of Cardiology (STS/ACC) Transcatheter Valve Therapy Registry (TVT Registry™). Additionally, longer-term safety and effectiveness will be monitored using linkage to CMS claims data for outcomes and adverse events starting with the end of one-year post-implant through five years post-implant.
Study Population Description All patients with an attempted LOTUS Edge valve implant in the aortic position, and entered into the TVT Registry, from the date of PMA approval (April 23, 2019) through June 30, 2021.
Sample Size There is no minimum sample size. It is anticipated that approximately 2000 patients will receive an attempted LOTUS Edge implant during this time period and will be entered into the TVT Registry.
Data Collection This surveillance will monitor the following: (1) device success (intra-procedure); (2) all-cause mortality, all stroke, life-threatening/major bleeding, new requirement for dialysis, peri-procedural myocardial infarction, and repeat procedure for valve-related dysfunction (surgical or interventional therapy) at 30 days and 12 months; (3) neurological (non-stroke), vascular complications, and quality of life (KCCQ) outcomes at 30 days and 12 months; and (4) all-cause mortality, all stroke, and repeat procedure for valve-related dysfunction (surgical or interventional therapy) at 2-5 year post implantation.
Follow-up Visits and Length of Follow-up Successfully implanted patients will be followed through the registry for one year, and patients who can be linked to CMS claims data will be followed through five years. Patients with attempted but unsuccessful implants will be followed through discharge.


RWU of LOTUS Edge Valve System Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/22/2019 10/16/2019 On Time
one year report 04/22/2020 04/22/2020 On Time
18 month report 10/21/2020    
two year report 04/22/2021    
30 month report 10/21/2021    
three year report 04/22/2022    
four year report 04/22/2023    


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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