PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III
Endotronix, Inc. · NCT05934487
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 1750
- US sites recruiting
- 44
- Study start
- November 29, 2023
- Record last updated
- June 29, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Cordella™ Pulmonary Artery Sensor System
Conditions: Heart Failure NYHA Class II; Heart Failure NYHA Class III; Heart Failure
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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 LVEF) for ≥ 3 months and NYHA Class II HF (NYHA II Cohort) or NYHA III (NYHA III Cohort) at time of Screening
- 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
Exclusion Criteria
- 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
- 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 \<2 years
- 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
Recruiting US locations
St. Joseph's Hospital and Medical Center
Phoenix, AZ 85013
Site contact: Namit Rohant, MD
USC
Los Angeles, CA 90033
Site contact: Aaron Wolfson
UCSF Medical Center
San Francisco, CA 94143
Site contact: Mark Lacsamana
Baptist Health South Florida
Miami, FL 33176
Site contact: Kenia Capdevilla
Ascension Sacred Heart
Pensacola, FL 32504
Site contact: Ana Rosa · ana.rosas@ascension.org
Piedmont
Atlanta, GA 30309
Site contact: Gigi Davis, RN
Advocate Health System
Downers Grove, IL 60515
Site contact: Tracy Geisler, CRC
Heart Care Centers of Illinois (HCCI)
Palos Park, IL 60464
Site contact: Jessica Kwak
Ascension St. Vincent's
Indianapolis, IN 46260
Site contact: Taylor Gilliam
University of Kansas Medical Center (KUMC)
Kansas City, KS 66160
Site contact: Yolanda Murr
MedStar
Baltimore, MD 21239
Site contact: Rebecca Comaty
Tufts Medical Center
Boston, MA 02111
Site contact: Gaurav Das
Ascension Providence Hospital Cardiology - Heart Cardiology
Howell, MI 48843
Site contact: Yulia Abidov
University of Minnesota
Minneapolis, MN 55455
Site contact: Julie Dicken
Centra Care Heart Center
Saint Cloud, MN 56303
Site contact: Nathan Warnert
St. Lukes/ Mid-American Heart Institute
Kansas City, MO 64111
Site contact: Amanda Huffman
Mount Sinai West
New York, NY 10019
Site contact: Sajiny John
Mount Sinai
New York, NY 10029
Site contact: Noah Moss
Lenox Hill/ Northwell Health
New York, NY 10075
Site contact: Virgenmina (Angie) Lugaro
Stony Brook University Med Center
Stony Brook, NY 11794
Site contact: Indre Caikauskaite
UNC Medical Center
Durham, NC 27703
Site contact: William Mostertz · william_mostertz@med.unc.edu
Duke University
Durham, NC 27710
Site contact: Marat Fudim, MD
The Christ Hospital- Cincinnati
Cincinnati, OH 45219
Site contact: Sitaramesh Emani
University of Cincinnati
Cincinnati, OH 45267
Site contact: Harshada More
University Hospital (Cleveland)
Cleveland, OH 44106
Site contact: Monique Robinson, MD
Providence St. Vincent's - Portland
Portland, OR 97225
Site contact: Christopher Chien, MD · christopher.chien@providence.org
Oregon Health Science Portland
Portland, OR 97239
Site contact: John Halvorson
Penn State Health
Hershey, PA 17033
Site contact: Katie Loffredo
UPMC
Pittsburgh, PA 15213
Site contact: Rachel McGargle
Medical University of South Carolina (MUSC)
Charleston, SC 29425
Site contact: Kathryn Dowler · dowlerk@musc.edu
PRISMA Health- Upstate
Greenville, SC 29605
Site contact: Ken Alfieri
Sanford
Sioux Falls, SD 57105
Site contact: Diana Ibarra-Garcia
Vanderbilt
Nashville, TN 37232
Site contact: Jaime Rich
Austin Heart
Austin, TX 78756
Site contact: Leticia Janak
Medical City Healthcare Dallas
Dallas, TX 75240
Site contact: Mona Hedra
Baylor Scott & White -Dallas
Dallas, TX 75246
Site contact: Cesar Guerrero, MD
Baylor/Texas Heart
Houston, TX 77030
Site contact: Claudell Montano
Methodist San Antonio
San Antonio, TX 78229
Site contact: Marina Martin
Baylor - Temple
Temple, TX 76508
Site contact: Amy Watts
University of Vermont
Burlington, VT 05401
Site contact: Meghan Sesera, RN
Providence Everett
Everett, WA 98201
Site contact: Becca Watson
West Virginia University
Morgantown, WV 26506
Site contact: Marvin Hudson
University of Wisconsin
Madison, WI 53792
Site contact: Karen Olson
Advocate Aurora St. Luke's
Milwaukee, WI 53215
Site contact: Nasir Sulemanjee, MD
Study contacts (from the official record)
- Sarah Walton · (630) 473-3200 · sarah_walton@edwards.com
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