Real World Effectiveness of the Cordella Pulmonary Artery Sensor System in Patients With Chronic Heart Heart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEndotronix, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Received Cordella PA Sensor System implant between 10/1/2024-12/31/2029
Documented chronic heart failure with NYHA Class III symptoms
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
Disqualifiers
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
Trial population
Patients with NYHA III chronic HF
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Cordella PA Sensor System
Device* Patients who receive the Cordella PA Sensor System for monitoring chronic heart failure * These patients will be monitored for 2 years after receiving the device * Patients must be on guideline-directed medical therapy appropriate for their ejection fraction status
Standard of Care Pharmacologic Therapy
Drug* Patients with chronic heart failure who receive standard medical care without PA pressure monitoring * These patients will be monitored for 2 years * Patients must be on guideline-directed medical therapy appropriate for their ejection fraction status
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
up to 24 monthsSecondary outcomes
1
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
Time frame
up to 24 months2
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
Time frame
up to 24 months3
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
Time frame
up to 24 months4
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
Time frame
up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov