Real World Effectiveness of the Cordella Pulmonary Artery Sensor System in Patients With Chronic Heart Heart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEndotronix, Inc.
About this trial
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 criteria
Qualifiers
Received Cordella PA Sensor System implant between 10/1/2024-12/31/2029
Documented chronic heart failure with NYHA Class III symptoms
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Cordella PA Sensor System
- Standard of Care Pharmacologic Therapy
Treatment groups
No treatment groups listed
Locations
1Endotronix60563, NapervilleIllinois, United States
Sponsors and collaborators
Endotronix, Inc.
Lead sponsor
Source ClinicalTrials.gov