Heart Failure NYHA Class IIILOWER-PAPNCT06783335
Real World Effectiveness of the Cordella Pulmonary Artery Sensor System in Patients With Chronic Heart Heart Failure
An observational study of Heart Failure NYHA Class III and Heart Failure, run by Endotronix, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure NYHA Class III, Heart Failure
- What is being tested?
- Cordella PA Sensor System
- Type of treatment
- Medical device
- How many people
- 2,150 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2025to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with NYHA III chronic HF
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Max Gill contact
United States1 site, 1 recruiting
- Recruiting
Endotronix
Naperville, Illinois, 60563
About this study
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
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.
Read the 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.
- Conditions
- Heart Failure NYHA Class III, Heart Failure
- Being tested
- Cordella PA Sensor System, Standard of Care Pharmacologic Therapy
- Keywords
- Heart failure, Heart Disease, Pulmonary Artery Pressure Sensor, Cardiovascular Disease, Cordella
- Medical subject headings
- Heart Failure, Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cordella PA Sensor SystemDevice
- 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 TherapyDrug
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 24 months
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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+
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start7 Feb 2025
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure NYHA Class IIIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endotronix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joanna VanHouten, PhD, Principal investigator, Endotronix, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783335
- Sponsor's protocol ID
- OS-2025-001
- Acronym
- LOWER-PAP
- Status last verified
- Nov 2025
- First submitted
- 14 Jan 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This study will leverage de-identified data sourced from Optum which has limits on sharing its proprietary data.
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06783335
- Acronym / sponsor ID
- LOWER-PAP / OS-2025-001
- Conditions
- Heart Failure NYHA Class III, Heart Failure
- Keywords
- Heart failure, Heart Disease, Pulmonary Artery Pressure Sensor, Cardiovascular Disease, Cordella
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,150 participants (estimated)
- Lead sponsor
- Endotronix, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Feb 2025 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with NYHA III chronic HF
Key inclusion criteria (12 listed)
- 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:
- Has continuous health insurance enrollment for 12 months prior to implant
- Two or more encounters with diagnosis codes for chronic systolic and/or diastolic heart failure
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cordella PA Sensor System* 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 | Device | – |
| Standard of Care Pharmacologic Therapy* 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 | Drug | – |
Primary outcome
Composite of All-cause Mortality and Heart Failure Hospitalizations
Time frame: 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
5 secondary outcomes
Composite Outcome in Racial and Ethnic Subgroups
Time frame: up to 24 months
Composite Outcome in Patients with Chronic Kidney Disease
Time frame: up to 24 months
Composite Outcome in Patients with Cardiac Devices
Time frame: up to 24 months
Composite Outcome in Patients by Ejection Fraction
Time frame: up to 24 months
Composite Outcome in Patients Age 75+
Time frame: up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No. This study will leverage de-identified data sourced from Optum which has limits on sharing its proprietary data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Max Gill contact
Joanna VanHouten, PhD principal investigator
Endotronix, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure NYHA Class III and Heart Failure, run by Endotronix, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Sauerland (630-599-7176, andrea_sauerland@edwards.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of All-cause Mortality and Heart Failure Hospitalizations (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.