PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III
NCT ID: NCT05934487
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1750 participants
INTERVENTIONAL
2023-11-29
2033-09-30
Brief Summary
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The study contains of 5 arms:
NYHA II Cohort - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class II HF patients, where patients have daily access to PAP data.
* Treatment Arm (Group 1)
* Active Control Arm (Group 2)
* Crossover Arm (Group 3)
NYHA III Cohort - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class III HF patients, where patients have daily access to PAP data, including a randomized sub-study to evaluate a clinician-directed patient self-management strategy.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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NYHA II Treatment Arm
All subjects will receive the Cordella Sensor.
Clinicians will manage the subjects to target PAP per protocols specific Treatment Guidelines and according to Guideline-Directed Medical Therapy.
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, with the goal of reducing heart failure hospitalizations. The system 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.
Cordella Sensor Cordella Delivery System myCordella Patient Reader Reader Dock Cordella Calibration Equipment (CalEQ) myCordella Tablet Cordella Data Analysis Platform (CDAP)
NYHA II Active Control Arm
All subjects will receive the Cordella Sensor.
Clinicians will manage subjects using the subjects daily data trends (BP, weight, HR, SpO2 symptoms) according to Guideline Directed Medical Therapy. Once the primary endpoint (24 months) is met, subjects and clinicians will be unblinded to PAP.
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, with the goal of reducing heart failure hospitalizations. The system 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.
Cordella Sensor Cordella Delivery System myCordella Patient Reader Reader Dock Cordella Calibration Equipment (CalEQ) myCordella Tablet Cordella Data Analysis Platform (CDAP)
NYHA II Crossover Arm
All subjects will receive the Cordella Sensor.
At least 12 months following implant and following an adjudicated HFH, subjects in the Active Control Arm can qualify to crossover to the Crossover Arm and both patients and clinicians would then be unmasked to PAP. Clinicians will then manage the subjects to target PAP per protocols specific Treatment Guidelines and according to Guideline-Directed Medical Therapy.
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, with the goal of reducing heart failure hospitalizations. The system 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.
Cordella Sensor Cordella Delivery System myCordella Patient Reader Reader Dock Cordella Calibration Equipment (CalEQ) myCordella Tablet Cordella Data Analysis Platform (CDAP)
NYHA III Phase I Treatment Arm
All subjects will receive the Cordella Sensor.
Clinicians will manage the subjects to target PAP per protocols specific Treatment Guidelines and according to Guideline-Directed Medical Therapy.
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, with the goal of reducing heart failure hospitalizations. The system 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.
Cordella Sensor Cordella Delivery System myCordella Patient Reader Reader Dock Cordella Calibration Equipment (CalEQ) myCordella Tablet Cordella Data Analysis Platform (CDAP)
NYHA III Phase I Active Control Arm
All subjects will receive the Cordella Sensor.
Clinicians will manage subjects using the subjects daily data trends (BP, weight, HR, SpO2 symptoms) according to Guideline Directed Medical Therapy. Once the primary endpoint (6 months) is met, subjects and clinicians will be unblinded to PAP.
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, with the goal of reducing heart failure hospitalizations. The system 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.
Cordella Sensor Cordella Delivery System myCordella Patient Reader Reader Dock Cordella Calibration Equipment (CalEQ) myCordella Tablet Cordella Data Analysis Platform (CDAP)
NYHA III Clinician-Directed Patient Self-Management Arm (randomized)
This is Phase II / Randomization #2 following implant provided patient meets eligiibity criteria.
Subjects will be instructed to take their PAP measurements daily in addition to their weight, BP, SpO2, and HR. All data, including PAP, will be visible to the patient. Subjects will manage their diuretics per protocol specific Clinician-Directed Patient Self-Management Treatment Guidelines. Clinicians will oversee the patient self-management to target PAP per protocol specific Treatment Guidelines and according to Guideline-Directed Medical Therapy.
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, with the goal of reducing heart failure hospitalizations. The system 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.
Cordella Sensor Cordella Delivery System myCordella Patient Reader Reader Dock Cordella Calibration Equipment (CalEQ) myCordella Tablet Cordella Data Analysis Platform (CDAP)
NYHA III Clinician Management Arm (randomized)
This is Phase II / Randomization #2 following implant provided patient meets eligiibity criteria.
Subjects will be instructed to take their PAP measurements daily in addition to their weight, BP, SpO2, and HR. All data, including PAP, will be visible to the patient. Subjects will manage their diuretics per protocol specific Clinician-Directed Patient Self-Management Treatment Guidelines. Clinicians will manage the patients to target PAP per protocols specific to Treatment Guidelines and according to Guideline Directed Medical Therapy.
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, with the goal of reducing heart failure hospitalizations. The system 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.
Cordella Sensor Cordella Delivery System myCordella Patient Reader Reader Dock Cordella Calibration Equipment (CalEQ) myCordella Tablet Cordella Data Analysis Platform (CDAP)
NYHA III Clinician Management Arm (Not randomized)
Subject will not be randomized if they do not meet eligibility criteria to potentially be randomized to Clinician-Directed Patient Self-Management.
Subjects will be instructed to take their PAP measurements daily in addition to their weight, BP, SpO2, and HR. All data, including PAP, will be visible to the patient. Subjects will manage their diuretics per protocol specific Clinician-Directed Patient Self-Management Treatment Guidelines. Clinicians will manage the patients to target PAP per protocols specific to Treatment Guidelines and according to Guideline Directed Medical Therapy.
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, with the goal of reducing heart failure hospitalizations. The system 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.
Cordella Sensor Cordella Delivery System myCordella Patient Reader Reader Dock Cordella Calibration Equipment (CalEQ) myCordella Tablet Cordella Data Analysis Platform (CDAP)
Interventions
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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, with the goal of reducing heart failure hospitalizations. The system 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.
Cordella Sensor Cordella Delivery System myCordella Patient Reader Reader Dock Cordella Calibration Equipment (CalEQ) myCordella Tablet Cordella Data Analysis Platform (CDAP)
Eligibility Criteria
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Inclusion Criteria
1. HFrEF (EF \< 50%): Subject has been on stable medications maximized to the subject's tolerance of ACE-I or ARB or ARNI, MRA, beta-blockers, and SGLT2i as determined by the study investigator for at least 30 days prior to Screening/Enrollment
2. HFpEF (EF ≥ 50%): Subject has been on stable medication maximized to the subject's tolerance of SGLT2i as determined by the study investigator for at least 30 days prior to Screening/Enrollment 5. NYHA II Cohort- HF related hospitalization within 6 months (last hospitalization should be 30 days before Screening /Enrollment) 5. NYHA III Cohort -HF related hospitalization within 12 month (last hospitalization should be 30 days before Screening/Enrollment)
6\. Subjects should be on diuretic therapy (≥40 mg\] furosemide or equivalent) for ≥ 1 month at time of Screening
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
2. Subjects with history of recurrent pulmonary embolism (≥2 episodes within 5 years prior to Screening Visit) and/or deep vein thrombosis in the femoral or IJ vein used for access (\< 3 month prior to Screening Visit)
3. Subjects with a resting systolic blood pressure \<90 mmHg and/ or severe pre-capillary pulmonary hypertension with a pulmonary artery systolic pressure of ≥70 mm/Hg with pulmonary capillary wedge pressure ≤ 15 mmHg at the Cordella PA Sensor Implant RHC (V2)
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 Cordella Sensor Implant Visit
12. Subjects with a GFR \<20 ml/min or who are on chronic renal dialysis
13. Implanted with Cardiac Resynchronization Therapy-Pacemaker (CRT-P) or Cardiac Resynchronization Therapy-Defibrillator (CRT-D), or having undergone mitral/tricuspid valve repair/replacement within 90 days or catheter ablation for atrial fibrillation within 30 days prior to screening visit
14. Received or are likely to receive an advanced therapy (e.g., durable mechanical circulatory support or lung or heart transplant) in the next 24 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 \<2 years
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
18 Years
ALL
No
Sponsors
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Endotronix, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Andrea Sauerland
Role: STUDY_DIRECTOR
Endotronix, Inc.
Locations
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St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
USC
Los Angeles, California, United States
UCSF Medical Center
San Francisco, California, United States
Baptist Health South Florida
Miami, Florida, United States
Ascension Sacred Heart
Pensacola, Florida, United States
Piedmont
Atlanta, Georgia, United States
Advocate Health System
Downers Grove, Illinois, United States
Heart Care Centers of Illinois (HCCI)
Palos Park, Illinois, United States
Ascension St. Vincent's
Indianapolis, Indiana, United States
University of Kansas Medical Center (KUMC)
Kansas City, Kansas, 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
Ascension Providence Hospital Cardiology - Heart Cardiology
Howell, 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
Washington University
St Louis, Missouri, United States
Mount Sinai West
New York, New York, United States
Mount Sinai
New York, New York, United States
Lenox Hill/ Northwell Health
New York, New York, United States
Stony Brook University Med Center
Stony Brook, New York, United States
Duke University
Durham, North Carolina, United States
The Christ Hospital- Cincinnati
Cincinnati, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
University Hospital (Cleveland)
Cleveland, Ohio, United States
Providence St. Vincent's - Portland
Portland, Oregon, United States
Oregon Health Science Portland
Portland, Oregon, United States
Penn State Health
Hershey, Pennsylvania, United States
UPMC
Pittsburgh, Pennsylvania, United States
PRISMA Health- Upstate
Greenville, South Carolina, United States
Sanford
Sioux Falls, South Dakota, United States
Vanderbilt
Nashville, Tennessee, United States
Austin Heart
Austin, Texas, United States
Medical City Healthcare Dallas
Dallas, Texas, United States
Baylor Scott & White -Dallas
Fort Worth, Texas, United States
Baylor/Texas Heart
Houston, Texas, United States
Methodist San Antonio
San Antonio, Texas, United States
Baylor - Temple
Temple, Texas, United States
University of Vermont
Burlington, Vermont, United States
Providence Everett
Everett, Washington, United States
West Virginia University
Morgantown, West Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
Advocate Aurora St. Luke's
Milwaukee, Wisconsin, United States
AZORG Aalst
Aalst, Aalst, Belgium
UZ Brussel
Brussels, , Belgium
University Hospital Galway
Galway, , Ireland
Countries
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Central Contacts
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Facility Contacts
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Namit Rohant, MD
Role: primary
Aaron Wolfson
Role: primary
Mark Lacsamana
Role: primary
Kenia Capdevilla
Role: primary
Walid Kara
Role: primary
Gigi Davis, RN
Role: primary
Jessica Kwak
Role: primary
Taylor Gilliam
Role: primary
Yolanda Murr
Role: primary
Rebecca Comaty
Role: primary
Gaurav Das
Role: primary
Yulia Abidov
Role: primary
Julie Dicken
Role: primary
Nathan Warnert
Role: primary
Amanda Huffman
Role: primary
Jean Flanagan
Role: primary
Sajiny John
Role: primary
Noah Moss
Role: primary
Virgenmina (Angie) Lugaro
Role: primary
Indre Caikauskaite
Role: primary
Harshada More
Role: primary
Monique Robinson, MD
Role: primary
Diana Ibarra-Garcia
Role: primary
Jaime Rich
Role: primary
Mona Hedra
Role: primary
Cesar Guerrero, MD
Role: primary
Marina Martin
Role: primary
Amy Watts
Role: primary
Becca Watson
Role: primary
Karen Olson
Role: primary
Other Identifiers
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ETX-HFS-PA-04
Identifier Type: -
Identifier Source: org_study_id
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