Phase
Condition
Congestive Heart Failure
Hyponatremia
Vascular Diseases
Treatment
Standard of Care Pharmacologic Therapy
Cordella PA Sensor System
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 diastolicheart failure
Documented ejection fraction reading within 6 months (+ or -) of second heartfailure 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
Exclusion Criteria:
No implanted pulmonary artery sensor or monitoring at any time (Standard of CareControl 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 postimplant (Cordella Cohort only)
Study Design
Study Description
Connect with a study center
Endotronix
Naperville, Illinois 60563
United StatesSite Not Available
Endotronix
Naperville 4903279, Illinois 4896861 60563
United StatesActive - Recruiting

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