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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P890003 S372/ PAS001 |
| Date Original Protocol Accepted |
09/01/2017
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| Date Current Protocol Accepted |
04/26/2024
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| Study Name |
Heart Failure Risk Status (HFRS) PAS
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| Device Name |
SYNERGYST II PULSE GENERATOR
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
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
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| Study Population |
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.
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| 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.
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| Key Study Endpoints |
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.
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| 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.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
1875
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| Actual Number of Sites Enrolled |
76
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| Patient Follow-up Rate |
Follow-up Rate The follow-up schedule for patients enrolled prospectively through the PSR is based on utilizing routine, scheduled office/clinic visits and unscheduled office/clinic visits prompted by symptoms or complaints, and CareLink transmissions (scheduled or unscheduled). For ICD and CRT patients, an in-person follow-up is anticipated to occur approximately every 3 to 9 months. Additionally, visits may be prompted by patient signs/symptoms and/or a patient’s high-risk status reported by HFRS. Transmission review of HFRS high-risk status include assessment of the HFRS report review status, clinician assessment of patient status (i.e. signs/symptoms, compliance, device parameters, and comorbidities), and clinical actions taken.
There were 27 missing CareLink follow-ups out of 29,528 CareLink follow-up months.
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| Final Safety Findings |
TriageHF algorithm is safe to use in combination with site assessment and follow up to help manage treatment/actions taken for heart failure patients.
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| Final Effect Findings |
The PPV was 48% (95% CI = 44-53%) for the overall cohort, with 232 out of 480 new high-risk alerts showing evidence of worsening heart failure reported within 45 days of the alert.
104 reported HF-related hospitalizations or deaths qualified to be included in the TriageHF sensitivity analysis (proportion of events preceded by a high-risk alert). To qualify, events must have occurred after 64 days of algorithm training and had a CareLink transmission within 30 days before the event. Of 104 fully qualified HF-related hospitalizations or deaths, 59 (57%; 95% CI = 47-66%) did not trigger a high-risk alert. Therefore, TriageHF has estimated 43% sensitivity to trigger high-risk alerts before qualifying HF-related hospitalizations of deaths.
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| Study Strengths & Weaknesses |
Strengths:
• Provides real-word evidence of HF management, integrating TriageHF alerts with clinical assessments and standard care pathways.
Weaknesses:
• TriageHF alert data is dependent on transmissions received by the site. TriageHF alert transmissions are not automatically triggered; they rely on another alert to automatically trigger a transmission, a scheduled transmission, or manual initiation by the patient.
• Confirmation of HF signs and symptoms, diagnosis, treatments and events depend on standard of care pathways per individual site assessments and documentation.
• Variability in standardized adjudication of events versus standard of care per site for assessments, including the timeframe the assessment took place.
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| Recommendations for Labeling Changes |
Recommend the study results are added to the labeling.
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