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Heart Failure NYHA Class IINCT05934487

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

A study testing Cordella™ Pulmonary Artery Sensor System in people with Heart Failure NYHA Class II and Heart Failure NYHA Class III, run by Endotronix, Inc. at 48 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cordella™ Pulmonary Artery Sensor System
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,750 participants
Where
48 sitesin 3 countries
Study dates
29 Nov 2023to Sep 2033
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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)
Show all 20Show fewer
  • 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

Trial locations and contacts

48 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Sarah Walton contact

(630) 473-3200

sarah_walton@edwards.com

48 sites in 3 countries

United States45 sites, 45 recruiting

  • Piedmont

    Atlanta, Georgia, 30309

    Gigi Davis, RN

    Kent Nilsson

    Recruiting

  • Austin Heart

    Austin, Texas, 78756

    Leticia Janak

    Faisal Syed, MD

    Recruiting

  • MedStar

    Baltimore, Maryland, 21239

    Rebecca Comaty

    Erika Feller

    Recruiting

  • Tufts Medical Center

    Boston, Massachusetts, 02111

    Gaurav Das

    Michael Kiernan, MD

    Recruiting

  • Boston Medical Center Corporation

    Boston, Massachusetts, 02118

    Nir Ayalon, MD

    Nir Ayalon, MD

    Not yet recruiting

  • University of Vermont

    Burlington, Vermont, 05401

    Meghan Sesera, RN

    Peter C Van Buren, MD

    Recruiting

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425

    Kathryn Dowler, dowlerk@musc.edu

    Vishal Rao

    Recruiting

  • The Christ Hospital- Cincinnati

    Cincinnati, Ohio, 45219

    Sitaramesh Emani

    Ankit Bhatia, MD

    Recruiting

  • University of Cincinnati

    Cincinnati, Ohio, 45267

    Harshada More

    Vlad Cotarlan, MD

    Recruiting

  • University Hospital (Cleveland)

    Cleveland, Ohio, 44106

    Monique Robinson, MD

    Monique Robinson, MD

    Recruiting

  • Medical City Healthcare Dallas

    Dallas, Texas, 75240

    Mona Hedra

    Claudius Mahr, MD

    Recruiting

  • Baylor Scott & White -Dallas

    Dallas, Texas, 75246

    Cesar Guerrero, MD

    Cesar Guerrero, MD

    Recruiting

  • Advocate Health System

    Downers Grove, Illinois, 60515

    Tracy Geisler, CRC

    Ali Valika

    Recruiting

  • UNC Medical Center

    Durham, North Carolina, 27703

    William Mostertz, william_mostertz@med.unc.edu

    William Mostertz, MD

    Recruiting

  • Duke University

    Durham, North Carolina, 27710

    Marat Fudim, MD

    Recruiting

  • Providence Everett

    Everett, Washington, 98201

    Becca Watson

    Feng Wang, MD

    Recruiting

  • PRISMA Health- Upstate

    Greenville, South Carolina, 29605

    Ken Alfieri

    Jason Guichard, MD

    Recruiting

  • Penn State Health

    Hershey, Pennsylvania, 17033

    Katie Loffredo

    John Boehmer, MD

    Recruiting

  • Baylor/Texas Heart

    Houston, Texas, 77030

    Claudell Montano

    Ajith Nair, MD

    Recruiting

  • Ascension Providence Hospital Cardiology - Heart Cardiology

    Howell, Michigan, 48843

    Yulia Abidov

    Marcel Zughaib, MD

    Recruiting

  • Ascension St. Vincent's

    Indianapolis, Indiana, 46260

    Taylor Gilliam

    Ashwin Ravichandran

    Recruiting

  • University of Kansas Medical Center (KUMC)

    Kansas City, Kansas, 66160

    Yolanda Murr

    Hirak Shah, MD

    Recruiting

  • St. Lukes/ Mid-American Heart Institute

    Kansas City, Missouri, 64111

    Amanda Huffman

    Michael Nassif, MD

    Recruiting

  • USC

    Los Angeles, California, 90033

    Aaron Wolfson

    Aaron Wolfson

    Recruiting

  • University of Wisconsin

    Madison, Wisconsin, 53792

    Karen Olson

    Peter Marogil, MD

    Recruiting

  • Baptist Health South Florida

    Miami, Florida, 33176

    Kenia Capdevilla

    Sandra Chaparro, MD

    Recruiting

  • Advocate Aurora St. Luke's

    Milwaukee, Wisconsin, 53215

    Nasir Sulemanjee, MD

    Nasir Sulemanjee, MD

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesota, 55455

    Julie Dicken

    Tamas Alexy, MD

    Recruiting

  • West Virginia University

    Morgantown, West Virginia, 26506

    Marvin Hudson

    Anantha Madgula, DO

    Recruiting

  • Vanderbilt

    Nashville, Tennessee, 37232

    Jaime Rich

    Sandip Zalawadiya, MD

    Recruiting

  • Mount Sinai West

    New York, New York, 10019

    Sajiny John

    Johanna Contreras, MD

    Recruiting

  • Mount Sinai

    New York, New York, 10029

    Noah Moss

    Noah Moss, MD

    Recruiting

  • Lenox Hill/ Northwell Health

    New York, New York, 10075

    Virgenmina (Angie) Lugaro

    Sirish Vullaganti, MD

    Recruiting

  • Heart Care Centers of Illinois (HCCI)

    Palos Park, Illinois, 60464

    Jessica Kwak

    Chirag Rajyaguru

    Recruiting

  • Ascension Sacred Heart

    Pensacola, Florida, 32504

    Ana Rosa, ana.rosas@ascension.org

    Rohit Amin

    Recruiting

  • St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

    Namit Rohant, MD

    Namit Rohant

    Recruiting

  • UPMC

    Pittsburgh, Pennsylvania, 15213

    Rachel McGargle

    Gavin Hickey, MD

    Recruiting

  • Providence St. Vincent's - Portland

    Portland, Oregon, 97225

    Christopher Chien, MD, christopher.chien@providence.org

    Christopher Chien

    Recruiting

  • Oregon Health Science Portland

    Portland, Oregon, 97239

    John Halvorson

    Luke Masha, MD

    Recruiting

  • Centra Care Heart Center

    Saint Cloud, Minnesota, 56303

    Nathan Warnert

    Jamie Pelzel, MD

    Recruiting

  • Methodist San Antonio

    San Antonio, Texas, 78229

    Marina Martin

    Chandra Kunavarapu

    Recruiting

  • UCSF Medical Center

    San Francisco, California, 94143

    Mark Lacsamana

    Shweta Motiwala, MD

    Recruiting

  • Sanford

    Sioux Falls, South Dakota, 57105

    Diana Ibarra-Garcia

    Marian Petrasko, MD

    Recruiting

  • Stony Brook University Med Center

    Stony Brook, New York, 11794

    Indre Caikauskaite

    Hal Skopicki, MD

    Recruiting

  • Baylor - Temple

    Temple, Texas, 76508

    Amy Watts

    Jaime Hernandez, MD

    Recruiting

Other trials in United States

Belgium2 sites

  • AZORG Aalst

    Aalst, 9300

    Active, not recruiting

  • UZ Brussel

    Brussels

    Active, not recruiting

Other trials in Belgium

Ireland1 site

  • University Hospital Galway

    Galway

    Active, not recruiting

Other trials in Ireland

About this study

Official title: 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

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:

Read more

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 tested
Cordella™ Pulmonary Artery Sensor System
Keywords
Heart Failure, Heart Disease, Cardiovascular Disease, Pulmonary Artery Pressure
Medical subject headings
Heart Failure, Heart Diseases, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cordella™ Pulmonary Artery Sensor SystemDevice

    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)

Study groups in NCT05934487
Study groupRoleWhat they receive
NYHA II Treatment ArmExperimentalAll 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.
Receives: Device: Cordella™ Pulmonary Artery Sensor System
NYHA II Active Control ArmExperimentalAll 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.
Receives: Device: Cordella™ Pulmonary Artery Sensor System
NYHA II Crossover ArmExperimentalAll 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.
Receives: Device: Cordella™ Pulmonary Artery Sensor System
NYHA III Phase I Treatment ArmExperimentalAll 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.
Receives: Device: Cordella™ Pulmonary Artery Sensor System
NYHA III Phase I Active Control ArmExperimentalAll 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.
Receives: Device: Cordella™ Pulmonary Artery Sensor System
NYHA III Clinician-Directed Patient Self-Management Arm (randomized)ExperimentalThis 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.
Receives: Device: Cordella™ Pulmonary Artery Sensor System
NYHA III Clinician Management Arm (randomized)ExperimentalThis 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.
Receives: Device: Cordella™ Pulmonary Artery Sensor System
NYHA III Clinician Management Arm (Not randomized)ExperimentalSubject 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.
Receives: Device: Cordella™ Pulmonary Artery Sensor System

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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

    Measured: 12 months

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

    Freedom from device/system related complication at 24 months

    Measured: 24 months

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

    Freedom from pressure sensor failure at 24 months

    Measured: 24 months

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

    Freedom from device/system related complication at 12 months

    Measured: 12 months

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

    Freedom from pressure sensor failure at 12 months

    Measured: 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

    Measured: 12 months

Secondary outcomes (28)

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

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

    Measured: 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

    Measured: 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

    Measured: 12 month

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

    Length of stay

    Measured: Duration of study (to 5 years)

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

    All-cause mortality

    Measured: Duration of study (to 5 years)

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

    Death from cardiovascular disease

    Measured: Duration of study (to 5 years)

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

    Urgent HF visits

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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.

    Measured: Duration of study (to 5 years)

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

    Heart failure related medication changes

    Measured: Duration of study (to 5 years)

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

    Change in PAP from baseline

    Measured: 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

    Measured: 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)

    Measured: 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

    Measured: 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,

    Measured: 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,

    Measured: Duration of study (to 5 years)

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

    Days alive outside hospital (DAOH)

    Measured: Duration of study (to 5 years)

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

    Health Economic Analysis

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Duration of study (to 5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2023
  2. Study start29 Nov 2023
  3. Primary completionSep 2028 (estimated)
  4. Study completionSep 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,750 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05934487
Sponsor's protocol ID
ETX-HFS-PA-04
Status last verified
Jun 2026
First submitted
26 Jun 2023
Last updated
29 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Cordella™ Pulmonary Artery Sensor System in people with Heart Failure NYHA Class II and Heart Failure NYHA Class III, run by Endotronix, Inc. at 48 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States, Belgium, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sarah Walton ((630) 473-3200, sarah_walton@edwards.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05934487.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.

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