Evaluating the Cordella Pulmonary Artery Sensor for Chronic Heart Failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• Endotronix
  Naperville, Illinois, United States Recruiting

Study contacts

• Principal investigator: Joanna VanHouten, PhD — Endotronix, Inc.
• Study coordinator: Andrea Sauerland
• Email: andrea_sauerland@edwards.com
• Phone: 630-599-7176

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Evaluating the Cordella Pulmonary Artery Sensor System for Heart Failure

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.