PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III
A Prospective, Multi-Center, Open Label, Randomized Control Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class II-III Heart Failure Patients
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how safe the Cordella Pulmonary Artery Sensor System is and how well it works for adults with class II or III heart failure. Patients can check pressure readings from a blood vessel in their lungs each day. Part of the study also tests patients managing their care with guidance from a clinician.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be at least 18 years old and give written consent to join.
- Have been diagnosed and treated for heart failure for at least 3 months, with class II or III heart failure at screening.
- Take the recommended heart failure medicines at steady doses for at least 30 days before screening. Some documented exceptions are allowed.
- Have had a heart failure hospital stay within 6 months for class II, or 12 months for class III. The last stay must be at least 30 days before screening.
- Take a water pill for at least 1 month: at least 40 mg of furosemide or an equal dose of another water pill.
- Be able to hold the 1.3-pound reader against your chest while seated for up to 2 minutes daily, and place it in and remove it from its base.
- Have enough vision, hearing, and thinking skills to use the reader, plus cell service or Wi-Fi at home.
- Agree and be able to return for all planned follow-up visits.
Who can't join
- Have severe heart failure that does not respond to treatment; certain severe heart valve or birth-related heart problems; or an artificial right-side heart valve.
- Have repeated lung blood clots, a recent clot in the leg or neck vein needed for the procedure, or a blood-clotting disorder.
- Have a resting top blood pressure number below 90, certain severe high pressures in lung blood vessels, or a heart attack, stroke, or other major heart event within 3 months.
- Cannot safely have the heart catheter test; have a life-threatening contrast dye allergy; or have allergies to certain clot-preventing medicines or cannot take the required medicines for 1 month after the implant.
- Have an active infection at the implant visit, kidney filtering below 20 ml/min, long-term dialysis, or another severe illness expected to limit life to less than 2 years.
- Recently had certain heart devices placed, valve repairs or replacements, or a procedure for an irregular heartbeat. Have received or are likely to need a long-term heart support device or heart or lung transplant within 24 months.
- Are pregnant or breastfeeding, are in another trial's active treatment group, or are in custody under an official or court order.
- Are unwilling to follow study rules, have a history of not following treatment plans, or are considered unsuitable by the study doctor.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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 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 sites (45)
AZ
- St. Joseph's Hospital and Medical Center · Phoenix, AZ 85013Namit Rohant, MD · Study contactNamit Rohant · Principal investigatorMore trials in Phoenix
CA
- USC · Los Angeles, CA 90033Aaron Wolfson · Study contactAaron Wolfson · Principal investigatorMore trials in Los Angeles
- UCSF Medical Center · San Francisco, CA 94143Mark Lacsamana · Study contactShweta Motiwala, MD · Principal investigatorMore trials in San Francisco
FL
- Baptist Health South Florida · Miami, FL 33176Kenia Capdevilla · Study contactSandra Chaparro, MD · Principal investigatorMore trials in Miami
- Ascension Sacred Heart · Pensacola, FL 32504Ana Rosa · Study contact · ana.rosas@ascension.orgRohit Amin · Principal investigatorMore trials in Pensacola
GA
- Piedmont · Atlanta, GA 30309Gigi Davis, RN · Study contactKent Nilsson · Principal investigatorMore trials in Atlanta
IL
- Advocate Health System · Downers Grove, IL 60515Tracy Geisler, CRC · Study contactAli Valika · Principal investigatorMore trials in Downers Grove
- Heart Care Centers of Illinois (HCCI) · Palos Park, IL 60464Jessica Kwak · Study contactChirag Rajyaguru · Principal investigatorMore trials in Palos Park
IN
- Ascension St. Vincent's · Indianapolis, IN 46260Taylor Gilliam · Study contactAshwin Ravichandran · Principal investigatorMore trials in Indianapolis
KS
- University of Kansas Medical Center (KUMC) · Kansas City, KS 66160Yolanda Murr · Study contactHirak Shah, MD · Principal investigatorMore trials in Kansas City
MA
- Tufts Medical Center · Boston, MA 02111Gaurav Das · Study contactMichael Kiernan, MD · Principal investigatorMore trials in Boston
- Boston Medical Center Corporation · Boston, MA 02118Nir Ayalon, MD · Study contactNir Ayalon, MD · Principal investigatorMore trials in Boston
MD
- MedStar · Baltimore, MD 21239Rebecca Comaty · Study contactErika Feller · Principal investigatorMore trials in Baltimore
MI
- Ascension Providence Hospital Cardiology - Heart Cardiology · Howell, MI 48843Yulia Abidov · Study contactMarcel Zughaib, MD · Principal investigatorMore trials in Howell
MN
- University of Minnesota · Minneapolis, MN 55455Julie Dicken · Study contactTamas Alexy, MD · Principal investigatorMore trials in Minneapolis
- Centra Care Heart Center · Saint Cloud, MN 56303Nathan Warnert · Study contactJamie Pelzel, MD · Principal investigatorMore trials in Saint Cloud
MO
- St. Lukes/ Mid-American Heart Institute · Kansas City, MO 64111Amanda Huffman · Study contactMichael Nassif, MD · Principal investigatorMore trials in Kansas City
NC
- UNC Medical Center · Durham, NC 27703William Mostertz · Study contact · william_mostertz@med.unc.eduWilliam Mostertz, MD · Principal investigatorMore trials in Durham
- Duke University · Durham, NC 27710Marat Fudim, MD · Principal investigatorMore trials in Durham
NY
- Mount Sinai West · New York, NY 10019Sajiny John · Study contactJohanna Contreras, MD · Principal investigatorMore trials in New York
- Mount Sinai · New York, NY 10029Noah Moss · Study contactNoah Moss, MD · Principal investigatorMore trials in New York
- Lenox Hill/ Northwell Health · New York, NY 10075Virgenmina (Angie) Lugaro · Study contactSirish Vullaganti, MD · Principal investigatorMore trials in New York
- Stony Brook University Med Center · Stony Brook, NY 11794Indre Caikauskaite · Study contactHal Skopicki, MD · Principal investigatorMore trials in Stony Brook
OH
- The Christ Hospital- Cincinnati · Cincinnati, OH 45219Sitaramesh Emani · Study contactAnkit Bhatia, MD · Principal investigatorMore trials in Cincinnati
- University of Cincinnati · Cincinnati, OH 45267Harshada More · Study contactVlad Cotarlan, MD · Principal investigatorMore trials in Cincinnati
- University Hospital (Cleveland) · Cleveland, OH 44106Monique Robinson, MD · Study contactMonique Robinson, MD · Principal investigatorMore trials in Cleveland
OR
- Providence St. Vincent's - Portland · Portland, OR 97225Christopher Chien, MD · Study contact · christopher.chien@providence.orgChristopher Chien · Principal investigatorMore trials in Portland
- Oregon Health Science Portland · Portland, OR 97239John Halvorson · Study contactLuke Masha, MD · Principal investigatorMore trials in Portland
PA
- Penn State Health · Hershey, PA 17033Katie Loffredo · Study contactJohn Boehmer, MD · Principal investigatorMore trials in Hershey
- UPMC · Pittsburgh, PA 15213Rachel McGargle · Study contactGavin Hickey, MD · Principal investigatorMore trials in Pittsburgh
SC
- Medical University of South Carolina (MUSC) · Charleston, SC 29425Kathryn Dowler · Study contact · dowlerk@musc.eduVishal Rao · Principal investigatorMore trials in Charleston
- PRISMA Health- Upstate · Greenville, SC 29605Ken Alfieri · Study contactJason Guichard, MD · Principal investigatorMore trials in Greenville
SD
- Sanford · Sioux Falls, SD 57105Diana Ibarra-Garcia · Study contactMarian Petrasko, MD · Principal investigatorMore trials in Sioux Falls
TN
- Vanderbilt · Nashville, TN 37232Jaime Rich · Study contactSandip Zalawadiya, MD · Principal investigatorMore trials in Nashville
TX
- Austin Heart · Austin, TX 78756Leticia Janak · Study contactFaisal Syed, MD · Principal investigatorMore trials in Austin
- Medical City Healthcare Dallas · Dallas, TX 75240Mona Hedra · Study contactClaudius Mahr, MD · Principal investigatorMore trials in Dallas
- Baylor Scott & White -Dallas · Dallas, TX 75246Cesar Guerrero, MD · Study contactCesar Guerrero, MD · Principal investigatorMore trials in Dallas
- Baylor/Texas Heart · Houston, TX 77030Claudell Montano · Study contactAjith Nair, MD · Principal investigatorMore trials in Houston
- Methodist San Antonio · San Antonio, TX 78229Marina Martin · Study contactChandra Kunavarapu · Principal investigatorMore trials in San Antonio
- Baylor - Temple · Temple, TX 76508Amy Watts · Study contactJaime Hernandez, MD · Principal investigatorMore trials in Temple
VT
- University of Vermont · Burlington, VT 05401Meghan Sesera, RN · Study contactPeter C Van Buren, MD · Principal investigatorMore trials in Burlington
WA
- Providence Everett · Everett, WA 98201Becca Watson · Study contactFeng Wang, MD · Principal investigatorMore trials in Everett
WI
- University of Wisconsin · Madison, WI 53792Karen Olson · Study contactPeter Marogil, MD · Principal investigatorMore trials in Madison
- Advocate Aurora St. Luke's · Milwaukee, WI 53215Nasir Sulemanjee, MD · Study contactNasir Sulemanjee, MD · Principal investigatorMore trials in Milwaukee
WV
- West Virginia University · Morgantown, WV 26506Marvin Hudson · Study contactAnantha Madgula, DO · Principal investigatorMore trials in Morgantown