NCT06783335 · Endotronix, Inc.
Real World Effectiveness of the Cordella Pulmonary Artery Sensor System in Patients With Chronic Heart Heart Failure
(LOWER-PAP)
What this study is about
This reviewing past data, non-randomly assigned group of participants 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.
View original scientific description
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 participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Naperville, Illinois
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 19, 2025 · Source of record for eligibility and locations