PROACTIVE-HF IDE Trial Heart Failure NYHA Class III

NCT ID: NCT04089059

Last Updated: 2025-03-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 738 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-10
• Study Completion Date: 2028-04-30

Brief 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).

Conditions

Heart Failure NYHA Class III

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Treatment Arm

Pulmonary 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).

Group Type: OTHER

Cordella™ Pulmonary Artery Sensor System

Intervention Type: DEVICE

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)

Interventions

Cordella™ Pulmonary Artery Sensor System

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)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subject has given written informed consent

2. Male or female, at least 18 years of age

3. Diagnosis and treatment of HF (regardless of left ventricular ejection fraction (LVEF)) for ≥ 3 months and NYHA Class III HF at time of Screening

4. 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.

5. 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:

1. Subjects with LVEF ≤ 50%: NT-proBNP ≥ 1500 pg/mL.

2. 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

6. Subjects should be on diuretic therapy

7. 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

8. 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

9. Subject has sufficient Cellular and/ or Wi- Fi Internet coverage at home

10. Subject agrees to return to the treating Investigator for all scheduled follow up visits and can return to the hospital for follow up

Exclusion Criteria

1. Intolerance to all neuro-hormonal antagonists (i.e., intolerance to ACE-I, ARB, ARNI, and beta-blockers) due to hypotension or renal dysfunction

2. ACC/AHA Stage D refractory HF (including having received or currently receiving pharmacologic circulatory support with inotropes)

3. 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)

4. Subjects who have had a major cardiovascular (CV) event (e.g. myocardial infarction, stroke) within 3 months of the Screening Visit

5. Unrepaired severe valvular disease

6. 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)

7. Subjects with known coagulation disorders

8. 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

9. Known history of life threatening allergy to contrast dye

10. Subjects whereby RHC is contraindicated

11. Subjects with an active infection at the Sensor Implant Visit

12. Subjects with a Glomerular Filtration Rate (GFR) <25 ml/min or who are on chronic renal dialysis

13. Implanted with Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or CRT-Defibrillator (CRT-D) for less than 90 days prior to screening visit

14. Received or are likely to receive an advanced therapy (e.g. mechanical circulatory support or lung or heart transplant) in the next 12 months

15. Subjects who are pregnant or breastfeeding

16. 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

17. Severe illness, other than heart disease, which would limit survival to <1 year

18. Subjects whose clinical condition, in the opinion of the Investigator, makes them an unsuitable candidate for the study

19. Subjects enrolled in another investigational trial with an active treatment arm

20. Subject who is in custody by order of an authority or a court of law

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endotronix, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrea Sauerland

Role: STUDY_DIRECTOR

Endotronix, Inc.

Locations

Ascension St Vincent's

Birmingham, Alabama, United States

Huntsville Hospital

Huntsville, Alabama, United States

Phoenix Cardiovascular Research Group/Insight

Phoenix, Arizona, United States

Loma Linda University

Loma Linda, California, United States

Eisenhower Medical Center

Rancho Mirage, California, United States

UCSD

San Diego, California, United States

Kaiser San Francisco

San Francisco, California, United States

UCSF Medical Center

San Francisco, California, United States

Kaiser Santa Clara

Santa Clara, California, United States

South Denver Cardiology

Littleton, Colorado, United States

Hartford Hospital

Hartford, Connecticut, United States

Baptist Health South Florida

Miami, Florida, United States

Ascension Sacred Heart

Pensacola, Florida, United States

USF Health

Tampa, Florida, United States

Cleveland Clinic

Weston, Florida, United States

Piedmont Athens

Athens, Georgia, United States

Queens Medical Center

Honolulu, Hawaii, United States

Northwestern

Chicago, Illinois, United States

U of Chicago

Chicago, Illinois, United States

Heart Centers of Illinois

Palos Park, Illinois, United States

OSF Healthcare

Peoria, Illinois, United States

Ascension St Vincent's

Indianapolis, Indiana, United States

University of Iowa Medical Center

Iowa City, Iowa, United States

University of Kansas Medical Center (KUMC)

Kansas City, Kansas, United States

University Of Louisville

Louisville, Kentucky, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

University of Maryland

Baltimore, Maryland, United States

Medstar

Baltimore, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center (BIDMC)

Boston, Massachusetts, United States

Brigham and Women's Hospital (Mass General Brigham)

Boston, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

University of Minnesota

Minneapolis, Minnesota, United States

Centra Care Heart Center

Saint Cloud, Minnesota, United States

St. Lukes/ Mid-American Heart Institute

Kansas City, Missouri, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

The Valley Hospital

Ridgewood, New Jersey, United States

Mount Sinai

New York, New York, United States

NYU Langone Health

New York, New York, United States

New York Presbyterian Queens

Queens, New York, United States

Stony Brook University Med Center

Stony Brook, New York, United States

University of Cincinnati

Cincinnati, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Oregon Health Science Portland

Portland, Oregon, United States

Thomas Jefferson Abington

Abington, Pennsylvania, United States

Penn State Health

Hershey, Pennsylvania, United States

Penn Medicine

Philadelphia, Pennsylvania, United States

Thomas Jefferson

Philadelphia, Pennsylvania, United States

UPMC

Pittsburgh, Pennsylvania, United States

PRISMA Midlands - Palmetto

Columbia, South Carolina, United States

PRISMA Health- Upstate

Greenville, South Carolina, United States

Sanford

Sioux Falls, South Dakota, United States

Tennova Healthcare (Turkey Creek Medical Center)

Knoxville, Tennessee, United States

Vanderbilt

Nashville, Tennessee, United States

Austin Heart

Austin, Texas, United States

Craig Cardiovascular Center

Gonzales, Texas, United States

Baylor/Texas Heart

Houston, Texas, United States

Houston Methodist

Houston, Texas, United States

University of Texas/Hermann Memorial

Houston, Texas, United States

Baylor - Round Rock

Round Rock, Texas, United States

Methodist Healthcare System

San Antonio, Texas, United States

Baylor - Temple

Temple, Texas, United States

University of Vermont

Burlington, Vermont, United States

Sentara Healthcare

Norfolk, Virginia, United States

Valley Health System/Winchester Medical Center

Winchester, Virginia, United States

University of Washington

Seattle, Washington, United States

Providence Health Care

Spokane, Washington, United States

West Virginia University

Morgantown, West Virginia, United States

University of Wisconsin

Madison, Wisconsin, United States

Cardiovascular Center OLV Aalst

Aalst, , Belgium

ZNA Middlheim

Antwerp, , Belgium

Ziekenhuis- Oost Limburg

Genk, , Belgium

University Hospital Galway

Galway, , Ireland

Countries

United States; Belgium; Ireland

References

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.

Reference Type: DERIVED

PMID: 39480670 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39152983 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ETX-HFS-PA-03

Identifier Type: -

Identifier Source: org_study_id