Cordella PA Sensor SystemStandard of Care Pharmacologic Therapy
Cordella PA Sensor System: * Patients who receive the Cordella PA Sensor System for monitoring chronic heart failure
* These patients will be monitored for 2 years after receiving the device
* Patients must be on guideline-directed medical therapy appropriate for their ejection fraction status
Standard of Care Pharmacologic Therapy: * Patients with chronic heart failure who receive standard medical care without PA pressure monitoring
* These patients will be monitored for 2 years
* Patients must be on guideline-directed medical therapy appropriate for their ejection fraction status
Study summary
This retrospective, non-randomized cohort study will evaluate how well the Cordella PA Sensor System works compared to standard medication treatment in people with chronic heart failure. The study will track patients for two years to see if those using the Cordella system have fewer deaths and hospitalizations related to heart failure.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria for Cordella PA Sensor System Cohort:
* Received Cordella PA Sensor System implant between 10/1/2024-12/31/2029
* Documented chronic heart failure with NYHA Class III symptoms
* On guideline-directed medical therapy based on ejection fraction status:
* For reduced EF (≤40%): At least one fill of ACE/ARB/ARNI, MRA, BB, or SGLT2i, and one fill of a loop diuretic
* For preserved EF (\>40%): At least one fill of a loop diuretic
* Has continuous health insurance enrollment for 12 months prior to implant
Inclusion Criteria for Standard of Care Control Cohort:
* Two or more encounters with diagnosis codes for chronic systolic and/or diastolic heart failure
* Documented ejection fraction reading within 6 months (+ or -) of second heart failure encounter
* On guideline-directed medical therapy based on ejection fraction status:
* For reduced EF (≤40%): At least one fill of ACE/ARB/ARNI, MRA, BB, or SGLT2i, and one fill of a loop diuretic
* For preserved EF (\>40%): At least one fill of a loop diuretic
* Has continuous health insurance enrollment for 12 months prior to study entry
Exclusion Criteria:
* No implanted pulmonary artery sensor or monitoring at any time (Standard of Care Control Cohort only)
* Record of temporary mechanical circulatory support during baseline period
* Diagnosis of cardiogenic shock during baseline period
* Receiving palliative care/hospice during baseline period
* Record of end-stage renal disease during baseline period
* Unable to take dual antiplatelet therapy or anticoagulants for one month post implant (Cordella Cohort only)
Primary outcome measure(s)
Composite of All-cause Mortality and Heart Failure Hospitalizations — up to 24 months * Description: The cumulative number of all-cause deaths and heart failure hospitalizations
* Time Frame: 2 years after study entry (time zero)
* Statistical Analysis Plan: The primary analysis will use an Andersen-Gill recurrent event model to account for multiple hospitalizations within individuals
* Primary outcome will be assessed in the overall population
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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