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

Endotronix, Inc. · NCT05934487

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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
PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III (NCT05934487) | Bored Studies