Actively Recruiting
Real World Effectiveness of the Cordella Pulmonary Artery Sensor System in Patients With Chronic Heart Heart Failure
Led by Endotronix, Inc. · Updated on 2025-11-19
2150
Participants Needed
1
Research Sites
307 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Real World Effectiveness of the Cordella Pulmonary Artery Sensor System in Patients With Chronic Heart Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Received Cordella PA Sensor System implant between 10/1/2024 and 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
- Two or more encounters with diagnosis codes for chronic systolic and/or diastolic heart failure (Standard of Care Control Cohort)
- Documented ejection fraction reading within 6 months (+ or -) of second heart failure encounter (Standard of Care Control Cohort)
- Has continuous health insurance enrollment for 12 months prior to study entry (Standard of Care Control Cohort)
You will not qualify if you...
- 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 or 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)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Endotronix
Naperville, Illinois, United States, 60563
Actively Recruiting
Research Team
A
Andrea Sauerland
CONTACT
M
Max Gill
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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