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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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Heart Failure Risk Status (HFRS) PAS

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Study Status Progress Adequate
Application Number P890003 S372/ PAS001
Date Current Protocol Accepted  
Study Name Heart Failure Risk Status (HFRS) PAS
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 Design Description To characterize clinical actions taken for each risk status as reported by HFRS report. The HFRS PAS is a US, prospective, observational, multi-center study
Study Population Description The study population includes all patients meeting the indication for a Medtronic ICD or CRT device approved for commercial release with the OptiVol fluid monitoring feature who participate in Medtronic’s CareLink Network and consent to the study.
Sample Size A sample size of 430 unique high risk transmissions will produce a two-sided 95% confidence interval with a width of less than 10% when the sample proportion is 65%, which was derived from the TRIAGE-HF study that worsening HF signs/symptoms were present in 65% of the High Risk Evaluations.
The HFRS PAS is designed to obtain a reliable estimate of the positive predictive value (PPV) of the HFRS High Status associated with worsening heart failure and to gain a better understanding of HF patient management practices. The HFRS PAS is based on several assumptions to estimate the timeframe needed to obtain a meaningful effective sample size for the parameter of interest including:
Number of eligible ICD/CRT system implants during the desired study duration
% of ICD/CRT patients who participate in Medtronic Carelink Network and transmit data through the network
Estimated number of transmissions/year/enrollment
% of transmissions with a HFRS High Risk Status
An estimated 2,000 patients implanted with an eligible device with a 60% CareLink participation rate and two transmissions per year will achieve the effective sample size for the parameter of interest within an estimated two-year period.
Data Collection Primary endpoint:
The positive predictive value (PPV) of HFRS High Risk Status associated with worsening
heart failure.
A true positive will be defined as a high-risk status and reported patient signs/symptoms
Positive Predictive Value will be calculated by dividing the number of True Positive by all transmissions reviewed with a high-risk status
Secondary endpoints
The number of HF hospitalization or HF related deaths that were not preceded by a High Risk Status
The purpose of this objective is to report on false negatives. The study will collect data on all incidences of HF related hospitalization and/or death, and identify if transmission data for 30-day period prior to the incidence is available. A patient with a reported HF hospitalization and/or death with available transmission data for 30-day period prior to the date of the reported event with no High-Risk Triggers will be reported regardless of whether the transmission was reviewed by the site. Reported HF related hospitalization or death with no transmission data availability within 30 days of the event will not be included for this objective.
This is a post market observational study by design, there is no formal interim analysis defined. However, the study will continuously monitor the status of clinician behavior: the proportion of transmissions when HFRS is reviewed will be summarized periodically. In addition, HF related events and hospitalization rates will be monitored in reports.
Follow-up Visits and Length of Follow-up Patients will be followed for a minimum of 12 months. The primary objective will be analyzed when the effective size of 430 patients with “High” risk trigger transmissions are collected or 3 years post-approval.
Interim or Final Data Summary
Interim Safety Information The sponsor stated that there have been 50 high risk alerts in 43 subjects from CareLink transmissions. This represents 3% of current CareLink transmissions. There have been 9 reported deaths, 24 reported patients exits, and 5 reported study deviations. There have been 17 HF events, of which 10 were HF related hospitalizations, as reviewed by the CEC.
Actual Number of Patients Enrolled 368
Actual Number of Sites Enrolled 40
Patient Follow-up Rate N/A
Study Strengths & Weaknesses The study is progressing adequately.

Heart Failure Risk Status (HFRS) PAS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 03/02/2018 03/01/2018 On Time
one year report 09/01/2018 08/22/2018 On Time
18 month report 03/02/2019 02/27/2019 On Time
two year report 09/01/2019 08/16/2019 On Time
three year report 08/31/2020 08/28/2020 On Time
4 year report 08/31/2021 08/25/2021 On Time
5 year report 08/31/2022 08/30/2022 On Time
6 year report 08/31/2023    

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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