Real World Effectiveness of the Cordella Pulmonary Artery Sensor System in Patients With Chronic Heart Heart Failure (LOWER-PAP)

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 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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Heart Failure NYHA Class III
• Intervention / Treatment: Device: Cordella PA Sensor System; Drug: Standard of Care Pharmacologic Therapy

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.

• Study Type: Observational
• Enrollment (Estimated): 2150

Contacts and Locations

• Study Contact: Name: Andrea Sauerland; Phone Number: 630-599-7176; Email: andrea_sauerland@edwards.com
• Study Contact Backup: Name: Max Gill; Email: max_gill@edwards.com

Study Locations

• United States
  • Illinois
    • Naperville, Illinois, United States, 60563
      • Recruiting
      • Endotronix

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with NYHA III chronic HF

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of All-cause Mortality and Heart Failure Hospitalizations	Description: The cumulative number of all-cause deaths and heart failure hospitalizations; Time Frame: 2 years after study entry (time zero); Statistical Analysis Plan: The primary analysis will use an Andersen-Gill recurrent event model to account for multiple hospitalizations within individuals; Primary outcome will be assessed in the overall population	up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Outcome in Racial and Ethnic Subgroups	The cumulative number of all-cause deaths and heart failure hospitalizations in: Black/African American patients; Asian patients; Hispanic patients	up to 24 months
Composite Outcome in Patients with Chronic Kidney Disease	The cumulative number of all-cause deaths and heart failure hospitalizations in patients with documented chronic kidney disease	up to 24 months
Composite Outcome in Patients with Cardiac Devices	The cumulative number of all-cause deaths and heart failure hospitalizations in patients with indwelling cardiac implantable electronic devices	up to 24 months
Composite Outcome in Patients by Ejection Fraction	The cumulative number of all-cause deaths and heart failure hospitalizations in patients with HF with reduced ejection fraction and patients with HF with preserved ejection fraction	up to 24 months
Composite Outcome in Patients Age 75+	The cumulative number of all-cause deaths and heart failure hospitalizations in patients age 75+	up to 24 months

Collaborators and Investigators

• Sponsor: Endotronix, Inc.
• Investigators: Principal Investigator: Joanna VanHouten, PhD, Endotronix, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: January 14, 2025
• First Submitted That Met QC Criteria: January 14, 2025
• First Posted (Actual): January 20, 2025

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Heart failure; Cardiovascular Disease; Heart Disease; Pulmonary Artery Pressure Sensor; Cordella
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: OS-2025-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This study will leverage de-identified data sourced from Optum which has limits on sharing its proprietary data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No