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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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Study Status Progress Adequate
Application Number P010012 S436/ PAS002
Date Current Protocol Accepted 08/26/2022
Study Name MANAGE-HF
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own Control
Analysis Type Analytical
Detailed Study Protocol Parameters
Study Design Description 1. To evaluate and optimize HeartLogic Heart Failure Diagnostics clinical integration and the alert management process (Phase I).
2. To evaluate Heart Logic in regards to patient outcomes of death and heart failure hospitalizations (Phase II).
Study Population Description Test Device: Phases I and II: ICD and CRT-D devices with HeartLogic turned ON
Control Device: Phase II: ICD and CRT-D devices with HeartLogic alerts turned OFF
Sample Size Between 1700 and 2700 subjects will be enrolled in the study:
Phase I: Up to 200 subjects
Up to 200 subjects are required in Phase I to build critical knowledge regarding the clinical integration of HeartLogic and the alert management process.
Phase II: 1500-2500 subjects
The sample size required for Phase II of MANAGE-HF is event-driven.
Between 1500 and 2500 subjects will be enrolled in the trial to accrue the necessary number of endpoint events to sufficiently power the primary endpoint. A total of 864 endpoints events from randomized subjects in Phase II are required to sufficiently power the primary endpoint, based on the following assumptions:
Expected control group incidence of annual heart failure
hospitalization and death = 20%
One-sided Alpha = 5%
Power = 90%
Hazard Ratio = 0.8
Estimated enrollment period = 24 months
Expected Follow-up period = minimum of 24 months for last patient enrolled
Final sample size will be determined during the study using a sample size re-estimation interim analysis.
Data Collection LATITUDE NXT 5.0 System
Follow-up Visits and Length of Follow-up Follow-Up Schedule:
Enrollment Visit
Baseline Visit
Scheduled follow-up Visits
Annual Phone Calls (6, 18,30, 42 months… from baseline)
Annual In-Clinic (12,24,36,48 months…from baseline visit)
Additional Follow-up Visits
HeartLogic Alert Action Visit
Additional Subject Interactions (i.e., Not in Response to HeartLogic Alerts)
End of Study Visit
Interim or Final Data Summary
Interim Safety Information There are no formal hypothesis for Phase I. Primary safety endpoint will be analyzed for
Phase II.
There have been 691 adverse events reported in 139 subjects (69.5% enrolled subjects). 59 in 28 subjects have been classified as related to a heart failure treatment resulting from a HeartLogic alert. There were three adverse events classified as related to the HeartLogic
algorithm by the site. There were no adverse events classified by BSC as related to the HeartLogic feature or algorithm.
Actual Number of Patients Enrolled 200 subjects have been enrolled across 33 sites globally as of the July 21, 2020 cut-off date
Actual Number of Sites Enrolled 33
Patient Follow-up Rate 144 Patients Completed Phase 1 / 200 total enrolled = 72 %
Study Strengths & Weaknesses Study enrollment is currently suspended due to the COVID-19 pandemic.
Phase II is currently being redesigned.

MANAGE-HF Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 10/31/2017 11/02/2017 Overdue/Received
one year report 05/02/2018 04/30/2018 On Time
18 month report 10/31/2018 10/31/2018 On Time
interim report 12/17/2018 12/17/2018 On Time
two year report 05/02/2019 05/01/2019 On Time
interim report 02/04/2020 02/04/2020 On Time
three year report 05/01/2020 05/01/2020 On Time
4 year report 05/01/2021 04/30/2021 On Time
5 year report 05/01/2022 08/08/2022 Overdue/Received
6 year report 05/02/2023    
7 year report 05/02/2024    
final report 09/28/2024    

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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