Real World Effectiveness of the Cordella Pulmonary Artery Sensor System in Patients With Chronic Heart Heart Failure
Recruiting · NCT06783335 · Observational (researchers observe without assigning treatment) · Lead sponsor: Endotronix, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
Cordella PA Sensor SystemStandard of Care Pharmacologic Therapy
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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)
Where it is running
1 location listed across 1 US state.
- Endotronix - Naperville, Illinois, United States