Recruiting

Proactive-HF-2

Sponsor:

Endotronix, Inc.

Code:

NCT05934487

Conditions

Heart Failure NYHA Class II

Heart Failure NYHA Class III

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cordella™ Pulmonary Artery Sensor System

Study Details

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

Study ID

NCT05934487

Start date

Nov 29, 2023

Status verified date

Jun, 2026

Completion date

Sep, 2033

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 LVEF) for ≥ 3 months and NYHA Class II HF (NYHA II Cohort) or NYHA III (NYHA III Cohort) at time of Screening

4\. 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.

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:
1. 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))
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

Study Design

Enrollment

1750 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

experimental: 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.

experimental: 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.

experimental: 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.

experimental: 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.

experimental: 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.

experimental: 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.

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, 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)

Primary outcome measure

  • Efficacy- NYHA II Cohort - A composite of first HF event or death from Cardiovascular Death up to 24 months. [ Time Frame: 24 months ]
  • Efficacy- NYHA III Cohort (Phase I) - a composite of HF events or death from cardiovascular disease at 6 months [ Time Frame: 12 months ]
  • Safety- Randomized Arm- Freedom from device/system related complication [ Time Frame: 24 months ]
  • Safety- Randomized Arm-Freedom from pressure sensor failure [ Time Frame: 24 months ]
  • Safety- Single Arm-Freedom from device/system related complication [ Time Frame: 12 months ]
  • Safety- Single Arm- Freedom from pressure sensor failure [ Time Frame: 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 [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

St. Joseph's Hospital and Medical Center

Recruiting

Phoenix, Arizona, United States, 85013

Principal Investigator:

Namit Rohant

USC

Recruiting

Los Angeles, California, United States, 90033

Principal Investigator:

Aaron Wolfson

UCSF Medical Center

Recruiting

San Francisco, California, United States, 94143

Principal Investigator:

Shweta Motiwala, MD

Baptist Health South Florida

Recruiting

Miami, Florida, United States, 33176

Principal Investigator:

Sandra Chaparro, MD

Ascension Sacred Heart

Recruiting

Pensacola, Florida, United States, 32504

Contacts

Principal Investigator:

Rohit Amin

Piedmont

Recruiting

Atlanta, Georgia, United States, 30309

Principal Investigator:

Kent Nilsson

Advocate Health System

Recruiting

Downers Grove, Illinois, United States, 60515

Principal Investigator:

Ali Valika

Heart Care Centers of Illinois (HCCI)

Recruiting

Palos Park, Illinois, United States, 60464

Principal Investigator:

Chirag Rajyaguru

Ascension St. Vincent's

Recruiting

Indianapolis, Indiana, United States, 46260

Principal Investigator:

Ashwin Ravichandran

University of Kansas Medical Center (KUMC)

Recruiting

Kansas City, Kansas, United States, 66160

Principal Investigator:

Hirak Shah, MD

MedStar

Recruiting

Baltimore, Maryland, United States, 21239

Principal Investigator:

Erika Feller

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Principal Investigator:

Michael Kiernan, MD

Ascension Providence Hospital Cardiology - Heart Cardiology

Recruiting

Howell, Michigan, United States, 48843

Principal Investigator:

Marcel Zughaib, MD

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Principal Investigator:

Tamas Alexy, MD

Centra Care Heart Center

Recruiting

Saint Cloud, Minnesota, United States, 56303

Principal Investigator:

Jamie Pelzel, MD

St. Lukes/ Mid-American Heart Institute

Recruiting

Kansas City, Missouri, United States, 64111

Principal Investigator:

Michael Nassif, MD

Mount Sinai West

Recruiting

New York, New York, United States, 10019

Principal Investigator:

Johanna Contreras, MD

Mount Sinai

Recruiting

New York, New York, United States, 10029

Principal Investigator:

Noah Moss, MD

Lenox Hill/ Northwell Health

Recruiting

New York, New York, United States, 10075

Principal Investigator:

Sirish Vullaganti, MD

Stony Brook University Med Center

Recruiting

Stony Brook, New York, United States, 11794

Principal Investigator:

Hal Skopicki, MD

UNC Medical Center

Recruiting

Durham, North Carolina, United States, 27703

Contacts

Principal Investigator:

William Mostertz, MD

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Principal Investigator:

Marat Fudim, MD

The Christ Hospital- Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45219

Principal Investigator:

Ankit Bhatia, MD

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45267

Principal Investigator:

Vlad Cotarlan, MD

University Hospital (Cleveland)

Recruiting

Cleveland, Ohio, United States, 44106

Principal Investigator:

Monique Robinson, MD

Providence St. Vincent's - Portland

Recruiting

Portland, Oregon, United States, 97225

Contacts

Principal Investigator:

Christopher Chien

Oregon Health Science Portland

Recruiting

Portland, Oregon, United States, 97239

Principal Investigator:

Luke Masha, MD

Penn State Health

Recruiting

Hershey, Pennsylvania, United States, 17033

Principal Investigator:

John Boehmer, MD

UPMC

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Principal Investigator:

Gavin Hickey, MD

Medical University of South Carolina (MUSC)

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Kathryn Dowler

dowlerk@musc.edu

Principal Investigator:

Vishal Rao

PRISMA Health- Upstate

Recruiting

Greenville, South Carolina, United States, 29605

Principal Investigator:

Jason Guichard, MD

Sanford

Recruiting

Sioux Falls, South Dakota, United States, 57105

Principal Investigator:

Marian Petrasko, MD

Vanderbilt

Recruiting

Nashville, Tennessee, United States, 37232

Principal Investigator:

Sandip Zalawadiya, MD

Austin Heart

Recruiting

Austin, Texas, United States, 78756

Principal Investigator:

Faisal Syed, MD

Medical City Healthcare Dallas

Recruiting

Dallas, Texas, United States, 75240

Principal Investigator:

Claudius Mahr, MD

Baylor Scott & White -Dallas

Recruiting

Dallas, Texas, United States, 75246

Principal Investigator:

Cesar Guerrero, MD

Baylor/Texas Heart

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Ajith Nair, MD

Methodist San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Principal Investigator:

Chandra Kunavarapu

Baylor - Temple

Recruiting

Temple, Texas, United States, 76508

Principal Investigator:

Jaime Hernandez, MD

University of Vermont

Recruiting

Burlington, Vermont, United States, 05401

Principal Investigator:

Peter C Van Buren, MD

Providence Everett

Recruiting

Everett, Washington, United States, 98201

Principal Investigator:

Feng Wang, MD

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26506

Principal Investigator:

Anantha Madgula, DO

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53792

Principal Investigator:

Peter Marogil, MD

Advocate Aurora St. Luke's

Recruiting

Milwaukee, Wisconsin, United States, 53215

Principal Investigator:

Nasir Sulemanjee, MD

More Information

Sponsor

Endotronix, Inc.

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Keywords

  • Heart Failure
  • Heart Disease
  • Cardiovascular Disease
  • Pulmonary Artery Pressure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Endotronix, Inc. on 2026-06-29.