Evaluating the Cordella Pulmonary Artery Sensor for Chronic Heart Failure

The Real-World Effectiveness of The Cordella Pulmonary Artery Sensor System in Patients With Chronic Heart Failure: A Comparative Analysis to Standard of Care Pharmacologic Therapy

This study is testing if a new device that monitors heart pressure at home can help people with chronic heart failure stay out of the hospital and live longer compared to just taking standard medications.

Quick facts

• Study type: Observational
• Enrollment: 2150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Endotronix, Inc. (industry)
• Locations: 1 site (Naperville, Illinois)
• Trial ID: NCT06783335 on ClinicalTrials.gov

What this trial studies

This observational study will assess the effectiveness of the Cordella Pulmonary Artery Sensor System in patients with chronic heart failure compared to standard medication treatment. It will track two groups of patients over two years: one using the Cordella system for home monitoring of heart pressure and the other receiving standard heart failure medications. The study aims to determine if the Cordella system leads to fewer hospitalizations and deaths related to heart failure. Special attention will be given to various demographics, including age, gender, and existing health conditions.

Who should consider this trial

Good fit: Ideal candidates include individuals with chronic heart failure classified as NYHA Class III who are receiving guideline-directed medical therapy.

Not a fit: Patients with heart failure who do not meet the inclusion criteria or those who are not on guideline-directed medical therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new method for monitoring heart failure that may reduce hospitalizations and improve survival rates.

How similar studies have performed: Other studies have shown promise in using remote monitoring systems for heart failure management, indicating potential success for this approach.

Eligibility criteria

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 this trial is running

Naperville, Illinois

• Endotronix — Naperville, Illinois, United States (RECRUITING)

Study contacts

• Principal investigator: Joanna VanHouten, PhD — Endotronix, Inc.
• Study coordinator: Andrea Sauerland

Conditions: Heart Failure NYHA Class III, Heart Failure, Heart failure, Heart Disease, Pulmonary Artery Pressure Sensor, Cardiovascular Disease, Cordella