Real World Effectiveness of the Cordella Pulmonary Artery Sensor System in Patients With Chronic Heart Heart Failure

Recruiting

• Conditions: Heart Failure NYHA Class III; Heart Failure

• Registration Number: NCT06783335
• Lead Sponsor: Endotronix, Inc.

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-14
• Study First Submitted QC: 2025-01-14
• Study First Posted: 2025-01-20
• Study Start: 2025-02-07
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-17
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2150

Inclusion Criteria

Not provided

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite of All-cause Mortality and Heart Failure Hospitalizations	up to 24 months	* 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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Endotronix; 🇺🇸 Naperville, Illinois, United States