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Heart Failure NYHA Class IIIPROACTIVE-HFNCT04089059

PROACTIVE-HF IDE Trial Heart Failure NYHA Class III

A study testing Cordella™ Pulmonary Artery Sensor System in people with Heart Failure NYHA Class III, run by Endotronix, Inc. at 74 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a prospective, open- label, single arm, multicenter clinical trial to evaluate the safety and effectiveness of the Cordella PA Sensor System in NYHA Class III Heart Failure Patients compared to a Performance Goal (PG). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure NYHA Class III
What is being tested?
Cordella™ Pulmonary Artery Sensor System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
738 participants
Where
74 sitesin 3 countries
Study dates
10 Jan 2020to Apr 2028
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Subject has given written informed consent
  • Male or female, at least 18 years of age
  • Diagnosis and treatment of HF (regardless of left ventricular ejection fraction (LVEF)) for ≥ 3 months and NYHA Class III HF at time of Screening
  • Subjects should be on stable, optimally titrated medical therapy for at least 30 days, as recommended according to current American Heart Association (AHA)/American College of Cardiology (ACC) guidelines as standard-of-care for HF therapy in the United States, or current European Society of Cardiology (ESC) guidelines for HF treatment in Europe, with any intolerance documented.
  • HF related hospitalization, HF treatment in a hospital day-care setting, or urgent outpatient clinic HF visit for IV diuretics within 12 month (last hospitalization should be 30 days before Screening/Enrollment) and/or N-terminal pro B-type Natriuretic Peptide (NT proBNP) at time of Screening/ Enrollment defined as:
  • Subjects with LVEF ≤ 50%: NT-proBNP ≥ 1500 pg/mL.
Show all 12Show fewer
  • Subjects with LVEF > 50%: NT-proBNP ≥ 800 pg/mL . Thresholds for NT-proBNP (for both LVEF ≤ 50% and LVEF > 50%) will be corrected for body mass index (BMI) using a 4% reduction per BMI unit over 25 kg/m2
  • Subjects should be on diuretic therapy
  • Subjects who are physically able to hold the myCordella™ Patient Reader unit (approximate weight 1.3lb) against the ventral thoracic surface for up to 2 minutes per day while in a seated position, as well as dock and undock the myCordella™ Patient Reader
  • Subjects with sufficient eyesight, hearing, and mental capacity to respond to the myCordella™ Patient Reader's audio/visual cues and operate the myCordella™ Patient Reader
  • Subject has sufficient Cellular and/ or Wi- Fi Internet coverage at home
  • Subject agrees to return to the treating Investigator for all scheduled follow up visits and can return to the hospital for follow up

Who cannot join

  • Intolerance to all neuro-hormonal antagonists (i.e., intolerance to ACE-I, ARB, ARNI, and beta-blockers) due to hypotension or renal dysfunction
  • ACC/AHA Stage D refractory HF (including having received or currently receiving pharmacologic circulatory support with inotropes)
  • Subjects with history of recurrent pulmonary embolism ( ≥2 episodes within 5 years prior to Screening Visit) and/or deep vein thrombosis (< 3 month prior to Screening Visit)
  • Subjects who have had a major cardiovascular (CV) event (e.g. myocardial infarction, stroke) within 3 months of the Screening Visit
  • Unrepaired severe valvular disease
  • Subjects with significant congenital heart disease that has not been repaired and would prevent implantation of the Cordella PA sensor or mechanical/tissue right heart valve(s)
Show all 20Show fewer
  • Subjects with known coagulation disorders
  • Subjects with a hypersensitivity or allergy to platelet aggregation inhibitors including aspirin, clopidogrel, prasugrel, and ticagrelor; or patients unable to take dual antiplatelet or anticoagulants for one-month post implant
  • Known history of life threatening allergy to contrast dye
  • Subjects whereby RHC is contraindicated
  • Subjects with an active infection at the Sensor Implant Visit
  • Subjects with a Glomerular Filtration Rate (GFR) <25 ml/min or who are on chronic renal dialysis
  • Implanted with Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or CRT-Defibrillator (CRT-D) for less than 90 days prior to screening visit
  • Received or are likely to receive an advanced therapy (e.g. mechanical circulatory support or lung or heart transplant) in the next 12 months
  • Subjects who are pregnant or breastfeeding
  • Subjects who are unwilling or deemed by the Investigator to be unwilling to comply with the study protocol, or subjects with a history of non-compliance
  • Severe illness, other than heart disease, which would limit survival to <1 year
  • Subjects whose clinical condition, in the opinion of the Investigator, makes them an unsuitable candidate for the study
  • Subjects enrolled in another investigational trial with an active treatment arm
  • Subject who is in custody by order of an authority or a court of law

Trial locations and contacts

74 sites in 3 countries.

74 sites in 3 countries

United States70 sites

  • Thomas Jefferson Abington

    Abington, Pennsylvania, 19001

  • Piedmont Athens

    Athens, Georgia, 30600

  • Austin Heart

    Austin, Texas, 78756

  • University of Maryland

    Baltimore, Maryland, 21201

  • Medstar

    Baltimore, Maryland, 21239

  • Ascension St Vincent's

    Birmingham, Alabama, 35235

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Beth Israel Deaconess Medical Center (BIDMC)

    Boston, Massachusetts, 02215

  • Brigham and Women's Hospital (Mass General Brigham)

    Boston, Massachusetts, 02215

  • University of Vermont

    Burlington, Vermont, 05401

  • Northwestern

    Chicago, Illinois, 60611

  • U of Chicago

    Chicago, Illinois, 60637

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • PRISMA Midlands - Palmetto

    Columbia, South Carolina, 29203

  • Ohio State University

    Columbus, Ohio, 43210

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Craig Cardiovascular Center

    Gonzales, Texas, 78155

  • PRISMA Health- Upstate

    Greenville, South Carolina, 29605

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Penn State Health

    Hershey, Pennsylvania, 17033

  • Queens Medical Center

    Honolulu, Hawaii, 96813

  • Baylor/Texas Heart

    Houston, Texas, 77030

  • Houston Methodist

    Houston, Texas, 77030

  • University of Texas/Hermann Memorial

    Houston, Texas, 77030

  • Huntsville Hospital

    Huntsville, Alabama, 35801

  • Ascension St Vincent's

    Indianapolis, Indiana, 46260

  • University of Iowa Medical Center

    Iowa City, Iowa, 52242

  • University of Kansas Medical Center (KUMC)

    Kansas City, Kansas, 66160

  • St. Lukes/ Mid-American Heart Institute

    Kansas City, Missouri, 64111

  • Tennova Healthcare (Turkey Creek Medical Center)

    Knoxville, Tennessee, 37934

  • South Denver Cardiology

    Littleton, Colorado, 80120

  • Loma Linda University

    Loma Linda, California, 92354

  • University Of Louisville

    Louisville, Kentucky, 40202

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Baptist Health South Florida

    Miami, Florida, 33176

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • West Virginia University

    Morgantown, West Virginia, 26506

  • Vanderbilt

    Nashville, Tennessee, 37232

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • Mount Sinai

    New York, New York, 10029

  • NYU Langone Health

    New York, New York, 11794

  • Sentara Healthcare

    Norfolk, Virginia, 22191

  • Heart Centers of Illinois

    Palos Park, Illinois, 60464

  • Ascension Sacred Heart

    Pensacola, Florida, 32504

  • OSF Healthcare

    Peoria, Illinois, 61107

  • Penn Medicine

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson

    Philadelphia, Pennsylvania, 19107

  • Phoenix Cardiovascular Research Group/Insight

    Phoenix, Arizona, 85018

  • UPMC

    Pittsburgh, Pennsylvania, 15213

  • Oregon Health Science Portland

    Portland, Oregon, 97239

  • New York Presbyterian Queens

    Queens, New York, 11355

  • Eisenhower Medical Center

    Rancho Mirage, California, 92270

  • The Valley Hospital

    Ridgewood, New Jersey, 07450

  • Baylor - Round Rock

    Round Rock, Texas, 78655

  • Centra Care Heart Center

    Saint Cloud, Minnesota, 56303

  • Methodist Healthcare System

    San Antonio, Texas, 78229

  • UCSD

    San Diego, California, 92037

  • Kaiser San Francisco

    San Francisco, California, 94118

  • UCSF Medical Center

    San Francisco, California, 94143

  • Kaiser Santa Clara

    Santa Clara, California, 95051

  • University of Washington

    Seattle, Washington, 98196

  • Sanford

    Sioux Falls, South Dakota, 57105

  • Providence Health Care

    Spokane, Washington, 99204

  • Stony Brook University Med Center

    Stony Brook, New York, 11794

  • USF Health

    Tampa, Florida, 33609

  • Baylor - Temple

    Temple, Texas, 76508

  • Cleveland Clinic

    Weston, Florida, 33331

  • Valley Health System/Winchester Medical Center

    Winchester, Virginia, 22601

Other trials in United States

Belgium3 sites

  • Cardiovascular Center OLV Aalst

    Aalst

  • ZNA Middlheim

    Antwerp

  • Ziekenhuis- Oost Limburg

    Genk

Other trials in Belgium

Ireland1 site

  • University Hospital Galway

    Galway

Other trials in Ireland

About this study

Official title: A Prospective, Multi-Center, Open Label, Single Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in NYHA Class III Heart Failure Patients (PROACTIVE- HF Trial)

This is a prospective, open- label, single arm, multicenter clinical trial to evaluate the safety and effectiveness of the Cordella PA Sensor System in NYHA Class III Heart Failure Patients compared to a Performance Goal (PG).

Being tested
Cordella™ Pulmonary Artery Sensor System
Keywords
Heart Failure, Heart Disease, Cardiovascular Disease, Pulmonary Artery Pressure
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™ Pulmonary Artery Sensor SystemDevice

    The Cordella PA Sensor System (CorPASS) is intended to measure, record, and transmit pulmonary artery pressure (PAP) data from NYHA Class III heart failure patients at home to clinicians for assessment and patient-centered heart failure management and comprises of seven subsystems that operate together to take daily Pulmonary Artery Pressure (PAP) readings at a patient's home and transmit the results to a care provider for evaluation.

    1. Cordella Sensor
    2. Cordella Delivery System
    3. myCordella Patient Reader
    4. Reader Dock
    5. Cordella Calibration Equipment (CalEQ)
    6. myCordella Hub
    7. Cordella Data Analysis Platform (CDAP)
Study groups in NCT04089059
Study groupRoleWhat they receive
Treatment ArmOtherPulmonary Artery Pressure Guided Heart Failure Management (PAPGHFM) and Guideline Directed Medical Therapy (GDMT) considering daily Pulmonary Artery Pressure (PAP) measurements and vital signs collected by Cordella Heart Failure System (CHFS).
Receives: Device: Cordella™ Pulmonary Artery Sensor System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy 6 Month Incidence of HF Related Hospitalizations (HFH) or All-cause Mortality

    The primary efficacy endpoint was the 6-month incidence of HF related hospitalizations or all-cause mortality in the modified Intent-to-Treat (mITT) population. As per the approved protocol/CIP, for study success the upper confidence bound of the observed event rate in the mITT population was required to be less than the performance goal (PG) of 0.43 events per patient 6-month, or equivalently, the corresponding p-value from the hypothesis test of 6-month incidence rate compared to PG was less than 0.025. Furthermore, the observed incidence rate was required to be less than 0.37. The 6-month incidence rate was derived using a Poisson regression with the number of events as the dependent variable and the exposure time as an offset term. In these analyses, a subject's exposure time was defined as the time to death, early study discontinuation, or 6 months (whichever occurred first).

    Measured: 6 months

  2. Safety: Freedom From Device/System Related Complication

    A device/system related complication (DSRC) is defined as an AE that is, or is possibly, related to the device/system (Cordella PA Sensor or electronic components) and is either treated invasively (other than intramuscular medication or diagnostic RHC) or results in subject´s death or explant of the device. The first primary safety endpoint describes freedom from a DSRC through 6 months and was tested against the null rate of 90%.

    Measured: 6 months

  3. Safety: Freedom From Pressure Sensor Failure

    A pressure sensor failure (PSF) occurs when the sensor malfunctions to the point that no readings can be obtained from the sensor after all attempts are exhausted including troubleshooting the system to rule out any problems with the electronic components. The second primary safety endpoint describes freedom from Pressure Sensor Failure through 6 months, it was tested against the null rate of 95%.

    Measured: 6 months

Secondary outcomes (18)

  1. HF Hospitalizations

    Number of HF Hospitalizations at 6 months post-implant compared to the number of HF Hospitalizations in the 6 months prior to implant

    Measured: 6 Months prior to implant and 6 months post implant

  2. HF Hospitalizations or Emergency Department/Hospital Outpatient IV Diuretic Visits.

    Incidence rate of HF Hospitalizations, Emergency Department/ Hospital Outpatient IV diuretic visits of Former Control Arm and Modified Intent to Treat at 6 months post implant, added together with equal weighting into a total number of events.

    Measured: 6 months

  3. Mortality

    Cardiac and all-cause mortality

    Measured: 6 Months

  4. IV Diuretic Visits

    Intravenous (IV) diuretic visits

    Measured: 6 Months

  5. Pulmonary Artery Pressure (PAP)

    Change in PAP: a. From Baseline through 6 months in subjects with a baseline mPAP i. above target range ii. within or below target range iii. Overall

    Measured: 6 months

  6. Device Success

    Proportion of device success as documented by ability of the System to successfully transmit PAP data transmit PAP data

    Measured: 6 Months

  7. Kansas City Cardiomyopathy Questionnaire (KCCQ)

    The Quality of Life KCCQ questionnaire is a measure of health-related quality of life. It is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life related to Heart Failure. From 23-items, the Overall Summary Score (OSS) will be calculated. In the OSS, each of the 23 items are converted onto a 0 to 100 scale using this formula: (Raw score - Minimum Raw Score)/(Maximum Raw Score - Minimum Raw Score) * 100. Then these are averaged across the 23 items. A score of 100 (the maximum score) would indicate maximum quality of life relating to heart failure and a score of 0 (scale minimum) would indicate the worst possible quality of life relating to heart failure, with higher scores generally indicating higher quality of life.

    Measured: 6 Months

  8. NYHA

    New York Heart Association (NYHA) Classification at 6 months. The New York Heart Association (NYHA) Classification provides a way of classifying the extent of heart failure by classifying patients in one of four categories based on their limitations during physical activity and in degree of shortness of breath and or angina pain. Class I is the least severe and Class IV is the most severe. The classes are:

    Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.

    Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.

    Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances. Comfortable only at rest.

    Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.

    Measured: 6 Months

  9. 6-Minute Walk Test

    Functional status improvement, as measured by 6-Minute Walk Test total distance walked. The 6-Minute Walk Test (6MWT) is a test that measures the total distance an individual can walk on a flat, hard surface in 6 minutes. It is commonly used to evaluate functional exercise capacity in patients with conditions including heart failure. The minimum score possible is 0, which would represent an inability to walk any distance. There is no maximum score, as a patient could theoretically walk any distance in 6 minutes though 800 meters considered the top reference range, which is what would be expected by elite athletes. Higher score indicate greater higher exercise capacity and lower scores indicate lower exercise capacity.

    Measured: 6 Months

  10. Number and Percent of Patients With Serious Adverse Events

    Number and percent of patients with serious adverse events throughout the study (site-reported).

    Measured: 6 Months

  11. Incidence of HF Hospitalizations or All-cause Mortality

    Incidence of HF Hospitalizations or all-cause mortality at 12 months calculated from Poisson regression.

    Measured: 12 months

  12. N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)

    Change of N-terminal pro B-type Natriuretic Peptide (NT-proBNP) from Baseline through 6 months. NT-proBNP is a biomarker used to assess heart failure (HF). NT-proBNP levels vary widely and are reported in picograms per milliliter (pg/mL) or nanograms per liter (ng/L), with no predefined maximum value. Zero is a hypothetical minimum value though this is, in practice, not possible. In the current context, higher scores indicate more severe heart failure and lower levels indicate less severe heart failure.

    Measured: 6 months

  13. Days Alive and Out of Hospital (DAOH)

    Days Alive and Out of Hospital (DAOH) during the 6 months after implant

    Measured: 6 Months

  14. Number of Heart Failure Related Medication Changes

    Number of patients (%) with heart failure related medication changes in the 6 months after implant

    Measured: 6 Months

  15. Number of HF Hospitalization or All-cause Mortality

    Number of HF Hospitalizations or all-cause mortality at 12 months

    Measured: 12 months

  16. Number of HF Hospitalization, Emergency Department/Hospital Outpatient IV Diuretic Visits, All-cause Mortality

    Number of combined outcome of:

    1. First and recurrent Heart Failure Hospitalizations
    2. Emergency Department / Hospital Outpatient IV diuretic visits all-cause mortality at 6 months, added together with equal weighting into a total number of events.

    Measured: 6 months

  17. Number of HF Hospitalization, Emergency Department/Hospital Outpatient IV Diuretic Visits

    Number of HF Hospitalization, Emergency Department/Hospital Outpatient IV diuretic visits at 6 months.

    Measured: 6 months

  18. Implant Procedure and Procedure Related Adverse Events and Serious Adverse Events

    Frequency of implant procedure and procedure related adverse events and serious adverse events

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2019
  2. Study start10 Jan 2020
  3. Primary completionApr 2028 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
738 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04089059
Sponsor's protocol ID
ETX-HFS-PA-03
Acronym
PROACTIVE-HF
Status last verified
Jul 2026
First submitted
30 Aug 2019
Last updated
24 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Guichard JL, Bonno EL, Nassif ME, Khumri TM, Miranda D, Jonsson O, Shah H, Alexy T, Macaluso GP, Sur J, Hickey G, McCann P, Cowger JA, Badiye A, Old WD, Raza Y, Masha L, Kunavarapu C, Bennett M, Sharif F, Kiernan M, Mullens W, Chaparro SV, Mahr C, Amin RR, Hiivala NJ, Owens MM, Sauerland A, Forouzan O, Klein L. Seated Pulmonary Artery Pressure Management in Patients With Heart Failure: 12-Month Outcomes of the PROACTIVE-HF Trial. JACC Heart Fail. 2026 Jun;14(6):102847. doi: 10.1016/j.jchf.2025.102847. Epub 2026 Feb 13.

    PubMed 41686133

  • Pourafshar N, Daneshmand A, Karimi A, Wilcox CS. Methods for the Assessment of Volume Overload and Congestion in Heart Failure. Kidney360. 2024 Oct 1;5(10):1584-1593. doi: 10.34067/KID.0000000000000553. Epub 2024 Aug 20.

    PubMed 39480670

  • Guichard JL, Bonno EL, Nassif ME, Khumri TM, Miranda D, Jonsson O, Shah H, Alexy T, Macaluso GP, Sur J, Hickey G, McCann P, Cowger JA, Badiye A, Old WD, Raza Y, Masha L, Kunavarapu CR, Bennett M, Sharif F, Kiernan M, Mullens W, Chaparro SV, Mahr C, Amin RR, Stevenson LW, Hiivala NJ, Owens MM, Sauerland A, Forouzan O, Klein L. Seated Pulmonary Artery Pressure Monitoring in Patients With Heart Failure: Results of the PROACTIVE-HF Trial. JACC Heart Fail. 2024 Nov;12(11):1879-1893. doi: 10.1016/j.jchf.2024.05.017. Epub 2024 Aug 14.

    PubMed 39152983

Questions about this trial

What is this clinical trial studying?

A study testing Cordella™ Pulmonary Artery Sensor System in people with Heart Failure NYHA Class III, run by Endotronix, Inc. at 74 sites in 3 countries.

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 20 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: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United States, Belgium, Ireland. 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?

Yes. Results are posted in the registry (first posted 3 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy 6 Month Incidence of HF Related Hospitalizations (HFH) or All-cause Mortality (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04089059, which also lists 3 linked publications.

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 24 Jul 2026.

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