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RecruitingNCT05934487Updated Jun 29, 2026

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

An interventional study of Cordella™ Pulmonary Artery Sensor System in Heart Failure NYHA Class II, Heart Failure NYHA Class III and Heart Failure, sponsored by Endotronix, Inc.. Recruiting at 48 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-29.

Sponsored by Endotronix, Inc. · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Nov 2023; still recruiting 2 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,750
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Heart Failure NYHA Class II
  • Heart Failure NYHA Class III
  • Heart Failure

Keywords

  • Heart Failure
  • Heart Disease
  • Cardiovascular Disease
  • Pulmonary Artery Pressure
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 1,750 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Endotronix, Inc. is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
1,750 participants (estimated)

Study 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.

    Device: Cordella™ Pulmonary Artery Sensor System

  • 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.

    Device: Cordella™ Pulmonary Artery Sensor System

  • 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.

    Device: Cordella™ Pulmonary Artery Sensor System

  • 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.

    Device: Cordella™ Pulmonary Artery Sensor System

  • 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.

    Device: Cordella™ Pulmonary Artery Sensor System

  • 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.

    Device: Cordella™ Pulmonary Artery Sensor System

  • 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.

    Device: Cordella™ Pulmonary Artery Sensor System

  • 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.

    Device: Cordella™ Pulmonary Artery Sensor System

Interventions

  • DeviceCordella™ 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)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24 months

  2. 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

    Time frame: 12 months

  3. Safety- Randomized Arm- Freedom from device/system related complication

    Freedom from device/system related complication at 24 months

    Time frame: 24 months

  4. Safety- Randomized Arm-Freedom from pressure sensor failure

    Freedom from pressure sensor failure at 24 months

    Time frame: 24 months

  5. Safety- Single Arm-Freedom from device/system related complication

    Freedom from device/system related complication at 12 months

    Time frame: 12 months

  6. Safety- Single Arm- Freedom from pressure sensor failure

    Freedom from pressure sensor failure at 12 months

    Time frame: 12 months

  7. 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

    Time frame: 12 months

Secondary outcomes

  1. Efficacy - NYHA II Cohort & NYHA III Cohort - HF Hospitalizations

    -Incidence of HFH at 12, 18, and 24 months

    Time frame: 12 months, 18 months and 24 months

  2. Efficacy - NYHA II Cohort & NYHA III Cohort- HF Hospitalizations

    -Number of HFH at 12- and 24-months post-implant compared to the number of HFH in the 12 and 24 months prior to implant

    Time frame: 12 months and 24 months

  3. Efficacy - NYHA II Cohort & NYHA III Cohort - HF Hospitalizations

    Combined outcome of : 1. First and recurrent HF Hospitalizations 2. Urgent HF Visits 3. all-cause mortality

    Time frame: 12 month

  4. Efficacy - NYHA II Cohort & NYHA III Cohort - HF Hospitalizations

    Length of stay

    Time frame: Duration of study (to 5 years)

  5. Efficacy - NYHA II Cohort & NYHA III Cohort - All-cause mortality

    All-cause mortality

    Time frame: Duration of study (to 5 years)

  6. Efficacy - NYHA II Cohort & NYHA III Cohort - Death from cardiovascular disease

    Death from cardiovascular disease

    Time frame: Duration of study (to 5 years)

  7. Efficacy - NYHA II Cohort & NYHA III Cohort - Urgent HF visits

    Urgent HF visits

    Time frame: Duration of study (to 5 years)

  8. Efficacy - NYHA II Cohort - Incidence of HF hospitalizations or all-cause mortality

    Incidence of HF hospitalizations or all-cause mortality

    Time frame: 12 months

  9. Efficacy - NYHA III Cohort - Composite of first HF event (HF hospitalization or urgent HF visit or death from cardiovascular disease (CVD)

    Composite of first HF event (HF hospitalization or urgent HF visit or

    Time frame: Up to 24 months

  10. Eff-NYHA II Cohort & NYHA III Cohort -time to death, # HFH or urgent HF visits, time to first HFH or urgent HF visit, diff >/= 15 KCCQ BSL to 24 mos,diff >/= 10 in KCCQ BSL to 24 mos, diff >/= 5 in KCCQ BSL to 24 mos, diff >/= 30m in 6 MWT BSL to 24 mos

    -time to death, # HFH or urgent HF visits, time to first HFH or urgent HF visit, diff \>/= 15 KCCQ BSL to 24 mos,diff \>/= 10 in KCCQ BSL to 24 mos, diff \>/= 5 in KCCQ BSL to 24 mos, diff \>/= 30m in 6 MWT BSL to 24 mos

    Time frame: Duration of study (to 5 years)

  11. Efficacy - NYHA II Cohort & NYHA III Cohort - Various measurements via ECHO and evaluated by ECHO core lab at Baseline, 12, 24, 36, 48 and 60 months.

    Various measurements via ECHO and evaluated by ECHO core lab at Baseline, 12, 24, 36, 48 and 60 months.

    Time frame: Duration of study (to 5 years)

  12. Efficacy - NYHA II Cohort & NYHA III Cohort - Heart failure related medication changes

    Heart failure related medication changes

    Time frame: Duration of study (to 5 years)

  13. Efficacy - NYHA II Cohort & NYHA III Cohort - Change in PAP from baseline

    Change in PAP from baseline

    Time frame: Duration of study (to 5 years)

  14. Efficacy - NYHA II Cohort & NYHA III Cohort - Change in PAP from baseline as measured by echocardiogram (ECHO) and evaluated by anECHO core lab at 12, 24, 36, 48, and 60 months

    Change in PAP from baseline as measured by echocardiogram (ECHO) and evaluated by an ECHO core lab at 12, 24, 36, 48, and 60 months

    Time frame: Duration of study (to 5 years)

  15. Efficacy - NYHA II Cohort & NYHA III Cohort - Patient Outcome Measures as measured by KCCQ, Brief Illness Perception Questionnaire, andEuroQol-5 Dimensions-5 Level (EQ-5D-5L)

    Patient Outcome Measures as measured by KCCQ, Brief Illness Perception Questionnaire, and EuroQol-5 Dimensions-5 Level (EQ-5D-5L)

    Time frame: Duration of study (to 5 years)

  16. Efficacy - NYHA II Cohort & NYHA III Cohort - Functional status improvement as measured by NYHA classification and 6MWT

    Functional status improvement as measured by NYHA classification and 6MWT

    Time frame: Duration of study (to 5 years)

  17. Efficacy - NYHA II Cohort & NYHA III Cohort - HFH stratified by ejection fraction (HFrEF, HFmrEF, HFpEF, and HF recovered EF) and baselineenrollment ECHO estimated systolic PAP

    HFH stratified by ejection fraction (HFrEF,

    Time frame: Duration of study (to 5 years)

  18. Efficacy - NYHA II Cohort & NYHA III Cohort - Mortality by baseline EF (HFrEF, HFmrEF, HFpEF, HF recovered EF), and baseline enrollmentECHO estimated systolic PAP

    Mortality by baseline EF (HFrEF, HFmrEF,

    Time frame: Duration of study (to 5 years)

  19. Efficacy - NYHA II Cohort & NYHA III Cohort - Days alive outside hospital (DAOH)

    Days alive outside hospital (DAOH)

    Time frame: Duration of study (to 5 years)

  20. Efficacy - NYHA II Cohort & NYHA III Cohort - Health Economic Analysis

    Health Economic Analysis

    Time frame: Duration of study (to 5 years)

  21. Efficacy - NYHA II Cohort & NYHA III Cohort - Adherence to regular PAP and vital sign measurements including a sub-analysis on subjectswho move to another area of the country

    Adherence to regular PAP and vital sign measurements including a sub-analysis on subjects who move to another area of the country

    Time frame: Duration of study (to 5 years)

  22. Safety - NYHA II Cohort - Freedom from device/system related complications at 12 months

    Freedom from device/system related complications at 12 months

    Time frame: Duration of study (to 5 years)

  23. Safety - NYHA III Cohort - Freedom from pressure sensor failure at 12 months

    Freedom from pressure sensor failure at 12 months

    Time frame: Duration of study (to 5 years)

  24. Safety - NYHA II Cohort & NYHA III Cohort - Pressure sensor failure rate throughout the study

    Pressure sensor failure rate throughout the study

    Time frame: Duration of study (to 5 years)

  25. Safety - NYHA II Cohort & NYHA III Cohort - Frequency of serious adverse events throughout the study

    Frequency of serious adverse events throughout the study

    Time frame: Duration of study (to 5 years)

  26. Safety - NYHA II Cohort & NYHA III Cohort - Frequency of implant procedure and procedure related adverse events and serious adverse events

    Frequency of implant procedure and procedure related adverse events and serious adverse events

    Time frame: Duration of study (to 5 years)

  27. Safety - NYHA III Cohort - Freedom from device/system related complications at 24 months

    Freedom from device/system related complications at 24 months

    Time frame: Duration of study (to 5 years)

  28. Safety - NYHA III Cohort - Freedom from pressure sensor failure at 24 months

    Freedom from pressure sensor failure at 24 months

    Time frame: 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

    Incidence of serious adverse events at 12 months post Phase II randomization

    Time frame: 12 months

07

Study locations

44 of 48 sites recruiting
  • St. Joseph's Hospital and Medical Center
    Phoenix, Arizona 85013, United States
    • Namit Rohant, MD · Contact
    • Namit Rohant · Principal investigator
    Recruiting
  • USC
    Los Angeles, California 90033, United States
    • Aaron Wolfson · Contact
    • Aaron Wolfson · Principal investigator
    Recruiting
  • UCSF Medical Center
    San Francisco, California 94143, United States
    • Mark Lacsamana · Contact
    • Shweta Motiwala, MD · Principal investigator
    Recruiting
  • Baptist Health South Florida
    Miami, Florida 33176, United States
    • Kenia Capdevilla · Contact
    • Sandra Chaparro, MD · Principal investigator
    Recruiting
  • Ascension Sacred Heart
    Pensacola, Florida 32504, United States
    Recruiting
  • Piedmont
    Atlanta, Georgia 30309, United States
    • Gigi Davis, RN · Contact
    • Kent Nilsson · Principal investigator
    Recruiting
  • Advocate Health System
    Downers Grove, Illinois 60515, United States
    • Tracy Geisler, CRC · Contact
    • Ali Valika · Principal investigator
    Recruiting
  • Heart Care Centers of Illinois (HCCI)
    Palos Park, Illinois 60464, United States
    • Jessica Kwak · Contact
    • Chirag Rajyaguru · Principal investigator
    Recruiting
  • Ascension St. Vincent's
    Indianapolis, Indiana 46260, United States
    • Taylor Gilliam · Contact
    • Ashwin Ravichandran · Principal investigator
    Recruiting
  • University of Kansas Medical Center (KUMC)
    Kansas City, Kansas 66160, United States
    • Yolanda Murr · Contact
    • Hirak Shah, MD · Principal investigator
    Recruiting
  • MedStar
    Baltimore, Maryland 21239, United States
    • Rebecca Comaty · Contact
    • Erika Feller · Principal investigator
    Recruiting
  • Tufts Medical Center
    Boston, Massachusetts 02111, United States
    • Gaurav Das · Contact
    • Michael Kiernan, MD · Principal investigator
    Recruiting
  • Boston Medical Center Corporation
    Boston, Massachusetts 02118, United States
    • Nir Ayalon, MD · Contact
    • Nir Ayalon, MD · Principal investigator
    Not yet recruiting
  • Ascension Providence Hospital Cardiology - Heart Cardiology
    Howell, Michigan 48843, United States
    • Yulia Abidov · Contact
    • Marcel Zughaib, MD · Principal investigator
    Recruiting
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
    • Julie Dicken · Contact
    • Tamas Alexy, MD · Principal investigator
    Recruiting
  • Centra Care Heart Center
    Saint Cloud, Minnesota 56303, United States
    • Nathan Warnert · Contact
    • Jamie Pelzel, MD · Principal investigator
    Recruiting
  • St. Lukes/ Mid-American Heart Institute
    Kansas City, Missouri 64111, United States
    • Amanda Huffman · Contact
    • Michael Nassif, MD · Principal investigator
    Recruiting
  • Mount Sinai West
    New York, New York 10019, United States
    • Sajiny John · Contact
    • Johanna Contreras, MD · Principal investigator
    Recruiting
  • Mount Sinai
    New York, New York 10029, United States
    • Noah Moss · Contact
    • Noah Moss, MD · Principal investigator
    Recruiting
  • Lenox Hill/ Northwell Health
    New York, New York 10075, United States
    • Virgenmina (Angie) Lugaro · Contact
    • Sirish Vullaganti, MD · Principal investigator
    Recruiting
  • Stony Brook University Med Center
    Stony Brook, New York 11794, United States
    • Indre Caikauskaite · Contact
    • Hal Skopicki, MD · Principal investigator
    Recruiting
  • UNC Medical Center
    Durham, North Carolina 27703, United States
    Recruiting
  • Duke University
    Durham, North Carolina 27710, United States
    • Marat Fudim, MD · Principal investigator
    Recruiting
  • The Christ Hospital- Cincinnati
    Cincinnati, Ohio 45219, United States
    • Sitaramesh Emani · Contact
    • Ankit Bhatia, MD · Principal investigator
    Recruiting
  • University of Cincinnati
    Cincinnati, Ohio 45267, United States
    • Harshada More · Contact
    • Vlad Cotarlan, MD · Principal investigator
    Recruiting
  • University Hospital (Cleveland)
    Cleveland, Ohio 44106, United States
    • Monique Robinson, MD · Contact
    • Monique Robinson, MD · Principal investigator
    Recruiting
  • Providence St. Vincent's - Portland
    Portland, Oregon 97225, United States
    Recruiting
  • Oregon Health Science Portland
    Portland, Oregon 97239, United States
    • John Halvorson · Contact
    • Luke Masha, MD · Principal investigator
    Recruiting
  • Penn State Health
    Hershey, Pennsylvania 17033, United States
    • Katie Loffredo · Contact
    • John Boehmer, MD · Principal investigator
    Recruiting
  • UPMC
    Pittsburgh, Pennsylvania 15213, United States
    • Rachel McGargle · Contact
    • Gavin Hickey, MD · Principal investigator
    Recruiting
  • Medical University of South Carolina (MUSC)
    Charleston, South Carolina 29425, United States
    • Kathryn Dowler · Contact · dowlerk@musc.edu
    • Vishal Rao · Principal investigator
    Recruiting
  • PRISMA Health- Upstate
    Greenville, South Carolina 29605, United States
    • Ken Alfieri · Contact
    • Jason Guichard, MD · Principal investigator
    Recruiting
  • Sanford
    Sioux Falls, South Dakota 57105, United States
    • Diana Ibarra-Garcia · Contact
    • Marian Petrasko, MD · Principal investigator
    Recruiting
  • Vanderbilt
    Nashville, Tennessee 37232, United States
    • Jaime Rich · Contact
    • Sandip Zalawadiya, MD · Principal investigator
    Recruiting
  • Austin Heart
    Austin, Texas 78756, United States
    • Leticia Janak · Contact
    • Faisal Syed, MD · Principal investigator
    Recruiting
  • Medical City Healthcare Dallas
    Dallas, Texas 75240, United States
    • Mona Hedra · Contact
    • Claudius Mahr, MD · Principal investigator
    Recruiting
  • Baylor Scott & White -Dallas
    Dallas, Texas 75246, United States
    • Cesar Guerrero, MD · Contact
    • Cesar Guerrero, MD · Principal investigator
    Recruiting
  • Baylor/Texas Heart
    Houston, Texas 77030, United States
    • Claudell Montano · Contact
    • Ajith Nair, MD · Principal investigator
    Recruiting
  • Methodist San Antonio
    San Antonio, Texas 78229, United States
    • Marina Martin · Contact
    • Chandra Kunavarapu · Principal investigator
    Recruiting
  • Baylor - Temple
    Temple, Texas 76508, United States
    • Amy Watts · Contact
    • Jaime Hernandez, MD · Principal investigator
    Recruiting
  • University of Vermont
    Burlington, Vermont 05401, United States
    • Meghan Sesera, RN · Contact
    • Peter C Van Buren, MD · Principal investigator
    Recruiting
  • Providence Everett
    Everett, Washington 98201, United States
    • Becca Watson · Contact
    • Feng Wang, MD · Principal investigator
    Recruiting
  • West Virginia University
    Morgantown, West Virginia 26506, United States
    • Marvin Hudson · Contact
    • Anantha Madgula, DO · Principal investigator
    Recruiting
  • University of Wisconsin
    Madison, Wisconsin 53792, United States
    • Karen Olson · Contact
    • Peter Marogil, MD · Principal investigator
    Recruiting
  • Advocate Aurora St. Luke's
    Milwaukee, Wisconsin 53215, United States
    • Nasir Sulemanjee, MD · Contact
    • Nasir Sulemanjee, MD · Principal investigator
    Recruiting
  • AZORG Aalst
    Aalst, 9300, Belgium
    Active, not recruiting
  • UZ Brussel
    Brussels, Belgium
    Active, not recruiting
  • University Hospital Galway
    Galway, Ireland
    Active, not recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05934487
Lead sponsor
Endotronix, Inc.
Responsible party
Sponsor
First posted
Jul 7, 2023
Start date
Nov 29, 2023
Primary completion
Sep 2028 (estimated)
Completion
Sep 2033 (estimated)
Last update
Jun 29, 2026

Study contacts

Sarah Walton
Contact
sarah_walton@edwards.com
(630) 473-3200
Edward Karst
study director · Edwards Lifesciences IHFM

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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