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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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OSB Lead-MANAGE-HF


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General
Study Status Progress Adequate
Application Number P960040 S385/ PAS002
Date Current Protocol Accepted  
Study Name OSB Lead-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
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
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



OSB Lead-MANAGE-HF Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/31/2017 11/02/2017 Overdue/Received
one year report 05/02/2018    
18 month report 10/31/2018    
two year report 05/02/2019    
three year report 05/01/2020    
four year report 05/01/2021    
five year report 05/01/2022    
Final Report 09/28/2024    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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