Clinical trial NCT06783335: Real World Effectiveness of the Cordella Pulmonary Artery Sensor System in Patients With Chronic Heart Heart Failure
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure NYHA Class III
Heart Failure
Keywords: Heart failure
Heart Disease
Pulmonary Artery Pressure Sensor
Cardiovascular Disease
Cordella
Lead sponsor: Endotronix, Inc.
Sponsor class: INDUSTRY
First posted: 2025-01-20
Enrollment: 2150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with NYHA III chronic HF

Brief summary: 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.

Detailed description: The study will compare two groups of patients with chronic heart failure:

* One group will use the Cordella PA Sensor System, which monitors heart pressure from home
* The other group will receive standard heart failure medications without a pressure monitoring system

The main goal is to see if patients using the Cordella system have fewer heart failure-related hospital stays and a lower death rate over a two-year period. The study will look especially closely at results for:

* Men and women separately
* Patients with different types of heart failure (preserved or reduced heart function)
* Patients aged 75 and older
* Different racial and ethnic groups
* Patients with kidney disease
* Patients with existing heart devices

The study will use real-world data from:

* Patients using the Cordella system in routine medical care
* Similar patients receiving standard care, identified through medical records and insurance claims Both groups of patients will be carefully matched to ensure they are similar in age, gender, and other important factors that could affect the results.

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)

Primary outcomes:
measure: Composite of All-cause Mortality and Heart Failure Hospitalizations
timeFrame: up to 24 months
Secondary outcomes:
measure: Composite Outcome in Racial and Ethnic Subgroups
timeFrame: up to 24 months
measure: Composite Outcome in Patients with Chronic Kidney Disease
timeFrame: up to 24 months
measure: Composite Outcome in Patients with Cardiac Devices
timeFrame: up to 24 months
measure: Composite Outcome in Patients by Ejection Fraction
timeFrame: up to 24 months
measure: Composite Outcome in Patients Age 75+
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Naperville
country: United States
facility: Endotronix
state: Illinois
Study officials:
affiliation: Endotronix, Inc.
name: Joanna Van Houten, PhD
role: PRINCIPAL_INVESTIGATOR
References: