PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III

NCT05934487 | Recruiting DMC FDA Device

• 1 other identifier: ETX-HFS-PA-04
• Study Type: interventional
• Target: 1,750
• Locations: 3 countries
• Sites: 49

Brief Summary

This is a prospective, multi-center, open label, randomized control clinical trial evaluating the safety and efficacy of the Cordella™ Pulmonary Artery Sensor System in NYHA Class II-III Heart Failure Patients (PROACTIVE-HF-2 Trial). 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.

Conditions

Heart Failure NYHA Class II; Heart Failure NYHA Class III; Heart Failure

Keywords

Heart Failure; Heart Disease; Cardiovascular Disease; Pulmonary Artery Pressure

Outcome Measures

Primary Outcomes (7)

• Efficacy- NYHA II Cohort - A composite of first HF event or death from Cardiovascular Death up to 24 months.

  A composite endpoint of first HF event or death from CVD up to 24 months.

  24 months

• Efficacy- NYHA III Cohort (Phase I) - a composite of HF events or death from cardiovascular disease at 6 months

  A composite of HF events or death from cardiovascular disease at 6 months

  12 months

• Safety- Randomized Arm- Freedom from device/system related complication

  Freedom from device/system related complication at 24 months

  24 months

• Safety- Randomized Arm-Freedom from pressure sensor failure

  Freedom from pressure sensor failure at 24 months

  24 months

• Safety- Single Arm-Freedom from device/system related complication

  Freedom from device/system related complication at 12 months

  12 months

• Safety- Single Arm- Freedom from pressure sensor failure

  Freedom from pressure sensor failure at 12 months

  12 months

• Efficacy- NYHA III Cohort (Phase II) - A test of non-inferiority at 12 months of the percentage of patients at or below trend seated mPAP of 25 mmHg in (i) Clinician-Directed Patient Self-Management vs. (ii) Clinician Management Arm

  A test of non-inferiority at 12 months of the percentage of patients at or below trend seated mPAP of 25 mmHg in (i) Clinician-Directed Patient Self-Management vs. (ii) Clinician Management Arm

  12 months

Secondary Outcomes (28)

• Efficacy - NYHA II Cohort & NYHA III Cohort - HF Hospitalizations

  12 months, 18 months and 24 months

• Efficacy - NYHA II Cohort & NYHA III Cohort- HF Hospitalizations

  12 months and 24 months

• Efficacy - NYHA II Cohort & NYHA III Cohort - HF Hospitalizations

  12 month

• Efficacy - NYHA II Cohort & NYHA III Cohort - HF Hospitalizations

  Duration of study (to 5 years)

• Efficacy - NYHA II Cohort & NYHA III Cohort - All-cause mortality

  Duration of study (to 5 years)

Other Outcomes (1)

• Safety - NYHA III Cohort Phase II only: Incidence of serious adverse events at 12 months post Phase II randomization

  12 months

Study Arms (8)

NYHA II Treatment Arm

EXPERIMENTAL

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.

Device: Cordella™ Pulmonary Artery Sensor System

NYHA II Active Control Arm

EXPERIMENTAL

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.

Device: Cordella™ Pulmonary Artery Sensor System

NYHA II Crossover Arm

EXPERIMENTAL

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.

Device: Cordella™ Pulmonary Artery Sensor System

NYHA III Phase I Treatment Arm

EXPERIMENTAL

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.

Device: Cordella™ Pulmonary Artery Sensor System

NYHA III Phase I Active Control Arm

EXPERIMENTAL

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.

Device: Cordella™ Pulmonary Artery Sensor System

NYHA III Clinician-Directed Patient Self-Management Arm (randomized)

EXPERIMENTAL

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.

Device: Cordella™ Pulmonary Artery Sensor System

NYHA III Clinician Management Arm (randomized)

EXPERIMENTAL

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.

Device: Cordella™ Pulmonary Artery Sensor System

NYHA III Clinician Management Arm (Not randomized)

EXPERIMENTAL

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.

Device: Cordella™ Pulmonary Artery Sensor System

Interventions

Cordella™ Pulmonary Artery Sensor System 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, 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; NYHA II Crossover Arm; NYHA II Treatment Arm; NYHA III Clinician Management Arm (Not randomized); NYHA III Clinician Management Arm (randomized); NYHA III Clinician-Directed Patient Self-Management Arm (randomized); NYHA III Phase I Active Control Arm; NYHA III Phase I Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Subjects should be receiving appropriate medical therapy for heart failure according to current AHA/ACC guidelines as standard-of-care for HF therapy in the United States, or current ESC guidelines for HF treatment in Europe for at least 30 days prior to the Screening/Enrollment visit. Stable is defined as no more than a 100% increase or 50% decrease in dose. These criteria may be waived if a subject is intolerant of ACE-I, ARB, ARNI), MRA, beta-blockers, or SGLT2i, subject is unable to afford these agents, subject has contraindications to these agents, or these agents are not indicated under the Guidelines. Such intolerance, lack of affordability, contraindications, or lack of indications must be documented.
• 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
• 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)
• \. Subjects should be on diuretic therapy (≥40 mg\] furosemide or equivalent) for ≥ 1 month at time of Screening
• \. 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

You may not qualify if:

• ACC/AHA Stage D refractory HF (including a known history of \>24 hours of IV inotropic therapy to support circulation within the past 6 months (other than relation to a procedure))
• 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)
• 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)
• 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)
• 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 Cordella Sensor Implant Visit
• Subjects with a GFR \<20 ml/min or who are on chronic renal dialysis
• 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
• 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
• Subjects who are pregnant or breastfeeding

Sponsors & Collaborators

• Endotronix, Inc.: lead

Study Sites (49)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

RECRUITING

USC

Los Angeles, California, 90033, United States

RECRUITING

UCSF Medical Center

San Francisco, California, 94143, United States

RECRUITING

Baptist Health South Florida

Miami, Florida, 33176, United States

RECRUITING

Ascension Sacred Heart

Pensacola, Florida, 32504, United States

RECRUITING

Piedmont

Atlanta, Georgia, 30309, United States

RECRUITING

Advocate Health System

Downers Grove, Illinois, 60515, United States

ACTIVE NOT RECRUITING

Heart Care Centers of Illinois (HCCI)

Palos Park, Illinois, 60464, United States

RECRUITING

Ascension St. Vincent's

Indianapolis, Indiana, 46260, United States

RECRUITING

University of Kansas Medical Center (KUMC)

Kansas City, Kansas, 66160, United States

RECRUITING

University of Maryland

Baltimore, Maryland, 21201, United States

ACTIVE NOT RECRUITING

MedStar

Baltimore, Maryland, 21239, United States

RECRUITING

Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

Beth Israel Deaconess Medical Center (BIDMC)

Boston, Massachusetts, 02215, United States

ACTIVE NOT RECRUITING

Ascension Providence Hospital Cardiology - Heart Cardiology

Howell, Michigan, 48843, United States

RECRUITING

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

ACTIVE NOT RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Centra Care Heart Center

Saint Cloud, Minnesota, 56303, United States

RECRUITING

St. Lukes/ Mid-American Heart Institute

Kansas City, Missouri, 64111, United States

RECRUITING

Washington University

St Louis, Missouri, 63110, United States

RECRUITING

Mount Sinai West

New York, New York, 10019, United States

RECRUITING

Mount Sinai

New York, New York, 10029, United States

RECRUITING

Lenox Hill/ Northwell Health

New York, New York, 10075, United States

RECRUITING

Stony Brook University Med Center

Stony Brook, New York, 11794, United States

RECRUITING

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

The Christ Hospital- Cincinnati

Cincinnati, Ohio, 45219, United States

ACTIVE NOT RECRUITING

University of Cincinnati

Cincinnati, Ohio, 45267, United States

RECRUITING

University Hospital (Cleveland)

Cleveland, Ohio, 44106, United States

RECRUITING

Providence St. Vincent's - Portland

Portland, Oregon, 97225, United States

RECRUITING

Oregon Health Science Portland

Portland, Oregon, 97239, United States

ACTIVE NOT RECRUITING

Penn State Health

Hershey, Pennsylvania, 17033, United States

ACTIVE NOT RECRUITING

UPMC

Pittsburgh, Pennsylvania, 15213, United States

ACTIVE NOT RECRUITING

PRISMA Health- Upstate

Greenville, South Carolina, 29605, United States

ACTIVE NOT RECRUITING

Sanford

Sioux Falls, South Dakota, 57105, United States

RECRUITING

Vanderbilt

Nashville, Tennessee, 37232, United States

RECRUITING

Austin Heart

Austin, Texas, 78756, United States

ACTIVE NOT RECRUITING

Medical City Healthcare Dallas

Dallas, Texas, 75240, United States

RECRUITING

Baylor Scott & White -Dallas

Fort Worth, Texas, 76110, United States

RECRUITING

Baylor/Texas Heart

Houston, Texas, 77030, United States

ACTIVE NOT RECRUITING

Methodist San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Baylor - Temple

Temple, Texas, 76508, United States

RECRUITING

University of Vermont

Burlington, Vermont, 05401, United States

ACTIVE NOT RECRUITING

Providence Everett

Everett, Washington, 98201, United States

RECRUITING

West Virginia University

Morgantown, West Virginia, 26506, United States

ACTIVE NOT RECRUITING

University of Wisconsin

Madison, Wisconsin, 53792, United States

RECRUITING

Advocate Aurora St. Luke's

Milwaukee, Wisconsin, 53215, United States

ACTIVE NOT RECRUITING

AZORG Aalst

Aalst, Aalst, 9300, Belgium

ACTIVE NOT RECRUITING

UZ Brussel

Brussels, Belgium

NOT YET RECRUITING

University Hospital Galway

Galway, Ireland

NOT YET RECRUITING

MeSH Terms

Conditions

Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Officials

• Andrea Sauerland

  Endotronix, Inc.

  STUDY DIRECTOR

Central Study Contacts

Andrea Sauerland

CONTACT

(630) 473-3200; clinical@endotronix.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 7, 2023
• Study Start: November 29, 2023
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2033
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1); US (46); BE (2)