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Heart Failure NYHA Class IIINCT04012944

SIRONA 2 Trial Heart Failure NYHA Class III

A study testing Cordella™ Pulmonary Artery Sensor System in people with Heart Failure NYHA Class III, run by Endotronix, Inc. at 7 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a prospective, multi-center, open-label, single-arm CE-Mark trial to assess device safety and efficacy of the Cordella PA Sensor System in up to 75 New York Heart Association (NYHA) Class III Heart Failure patients who will receive the Cordella PA Sensor Implant. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure NYHA Class III
What is being tested?
Cordella™ Pulmonary Artery Sensor System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
7 sitesin 3 countries
Study dates
26 Jun 2019to Dec 2031
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

  • Subject has given written informed consent
  • Male or female, at least 18 years of age
  • Diagnosis of HF ≥ 6 months with either preserved or reduced left ventricular ejection fraction (LVEF) and NYHA Class III HF at the time of Screening
  • HF related hospitalization, HF treatment in a hospital day-care setting, or unplanned outpatient clinic HF visit within 12 months prior to consent and/or increase of N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) (or Brain Natriuretic Peptide (BNP)) at time of Screening defined as:
  • Subjects with LVEF ≤ 40%: NT-proBNP ≥ 1000 pg/mL (or BNP ≥ 250 pg/mL).
  • Subjects with LVEF > 40%: NT-proBNP ≥ 700 pg/mL (or BNP ≥ 175 pg/mL). Thresholds for NT-proBNP and BNP (for both LVEF ≤ 40% and LVEF > 40%) will be corrected for body mass index (BMI) using a 4% reduction per BMI unit over 25 kg/m2
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  • Subjects must be receiving appropriate medical management of HF for 3 months prior to Screening and clinically stable for at least 1 month prior to study entry
  • Subjects who are physically able to hold the myCordella™ Patient Reader unit (approximate weight 600g) 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

Who cannot join

  • Subjects with primary pulmonary hypertension
  • Subjects with an active infection at the Cordella PA Sensor Implant Visit
  • Subjects with history of pulmonary embolism or deep vein thrombosis
  • Subjects who have had a major cardiovascular event (e.g., myocardial infarction, stroke) within 2 months of the Screening Visit
  • Subjects whereby RHC is contraindicated
  • Implanted with a Cardiac Rhythm Management (CRM) Device (Internal Cardiac Defibrillator (ICD) or pacemaker) or Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or CRT-Defibrillator (CRT-D) less than 90 days prior to screening visit
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  • Any major surgery within 30 days of the Sensor Implant Visit.
  • Subjects with a Glomerular Filtration Rate (GFR) <25 ml/min or who are on chronic renal dialysis
  • Specific liver enzymes [Aspartate Aminotransferase (AST) (SGOT), and Alanine Aminotransferase (ALT) (SGPT) >3 times the upper limit of normal
  • Received or are likely to receive an advanced therapy (e.g., mechanical circulatory support or lung or heart transplant) in the next 12 months
  • Subjects with congenital heart disease 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 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 <1 year
  • 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
  • Unrepaired severe valvular disease
  • Subjects with an inferior vena cava (IVC) filter

Trial locations and contacts

7 sites in 3 countries.

7 sites in 3 countries

Germany3 sites

  • Uniklinik Köln, Klinik III für Innere Medizin Herzzentrum der Universität zu Köln

    Cologne

  • Universitätsklinikum Giessen und Marburg GmbH, Standort Giessen Medizinische Klinik I, Abteilung Kardiologie und Angiologie

    Giessen

  • Klinik für Kardiologie und Angiologie/ Studienambulanz Medizinische Hochschule Hannover (MHH)

    Hanover

Other trials in Germany

Belgium2 sites

  • Cardivascular Center OLV Aalst

    Aalst

  • Ziekenhuis- Oost Limburg

    Genk

Other trials in Belgium

Ireland2 sites

  • Mater Misericordiae University Hospital

    Dublin

  • University Hospital Galway

    Dublin

Other trials in Ireland

About this study

Official title: A Prospective, Multi-Center, Open-Label, Single-Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class III Heart Failure Patients (SIRONA 2 Trial)

This is a prospective, multi-center, open-label, single-arm CE-Mark trial to assess device safety and efficacy of the Cordella PA Sensor System in up to 75 New York Heart Association (NYHA) Class III Heart Failure patients who will receive the Cordella PA Sensor Implant.

Read the detailed description

The study objectives are:

  1. To establish that the Cordella PA Sensor can be safely delivered, deployed, and remain stable within the target pulmonary artery (PA) segment through 30 days post-implant.
  2. To compare Cordella PA Sensor System pressure measurements with fluid-filled catheter PA pressure measurements obtained by standard right heart catheterization (RHC) at 90 days post implant.
Being tested
Cordella™ Pulmonary Artery Sensor System
Keywords
Heart Failure, Heart Diseases, Cardiovascular Disease
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 comprises 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.

    1. Cordella Sensor
    2. Cordella Delivery System
    3. myCordella Patient Reader
    4. Reader Dock
    5. Cordella Calibration Equipment (CalEQ)
    6. myCordella Hub
    7. Cordella Data Analysis Platform (CDAP).
Study groups in NCT04012944
Study groupRoleWhat they receive
Cordella™ Pulmonary Artery Sensor SystemExperimentalThe 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
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. Safety: Freedom from Adverse Events

    To evaluate the primary safety endpoint: Freedom from AEs associated with use of the CorPASS through 30 days post Cordella PA Sensor implant, the number of subjects with and without any Adverse Device Events will be summarized.

    Measured: 30 days

  2. Accuracy of Cordella PA Sensor System pressure measurements, compared to standard-of-care fluid-filled catheter PA pressure measurements obtained by standard Right Heart Catheterization (RHC)

    System accuracy will be compared to the accuracy of standard-of-care commercial products that use fluid-filled invasive catheters to measure PA pressure at 90 days post implant visit.

    Measured: 90 days

Secondary outcomes (13)

  1. Frequency of Adverse Events

    Frequency of adverse events throughout the study

    Measured: 30 days and 2 years

  2. Device/system-related complications

    The rate of device/system-related complications will be assessed throughout the study

    Measured: 30 days and 2 years

  3. Pressure sensor failure rate

    Pressure sensor failure rate throughout the study

    Measured: 30 days and 2 years

  4. Accuracy using the Bland Altman Method

    Accuracy of Cordella PA Sensor System pressure measurements, compared to standard-of-care fluid-filled catheter PA pressure measurements obtained by standard RHC using the Bland Altman method.

    Measured: 90 days

  5. Accuracy of Cordella PA Sensor pressure measurements

    Accuracy of Cordella PA Sensor System pressure measurements, compared to standard-of-care fluid-filled catheter PA pressure measurements obtained by standard RHC

    Measured: 12 months

  6. Device Success

    Percentage of device success as documented by ability of the System to successfully transmit collected PAP data to a secure database

    Measured: 90 days

  7. Change in Pulmonary Artery (PA) pressure

    Change in PA pressure:

    1. Pre- and post-implant
    2. Before and after 6-Minute Walk Test
    3. Sitting vs supine PA pressure measurements

    Measured: 90 days and 2 years

  8. HF related hospitalizations, treatments in a hospital day-care setting, or urgent outpatient clinic visits.

    Frequency of HF hospitalizations, HF treatments in a hospital day-care setting, or urgent outpatient clinic HF visits.

    Measured: 90 days and 2 years

  9. Quality of Life measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)

    The Quality of Life KCCQ questionnaire is a measure of health-related quality of life. It is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life related to Heart Failure. Out of 23-items, 10 scores will be calculated: Physical Limitation, Symptom Stability, Symptom Frequency, Symptom Burden, Total Symptom Score, Self-Efficacy, Quality of Life, Social Limitation, Overall Summary Score, Clinical Summary Score .Presentation will be done by means of descriptive statistics including the absolute value and change from baseline by visit.

    Measured: 90 days and 2 years

  10. Adherence to regular myCordella™ Peripherals measurements measured as a percentage of subjects who adhere to regular myCordella™ Peripherals measurements

    Subjects will be instructed to perform daily measurements throughout the study. Subject compliance will be defined as at least 5 days of data collection/transmissions per week.

    Measured: 90 days and 2 years

  11. Heart Failure related medication changes

    Heart failure related medication change will be collected and summarized by visit presenting the percentage of subjects with and without any change in Heart Failure related medication

    Measured: 90 days and 2 years

  12. Functional Status Change as measured by New York Heart Association (NYHA) functional classification

    The NYHA functional classification categorizes the extent of heart failure by placing subjects in one of four (I, II, III, IV) categories based on how much they are limited during physical activity and symptoms of shortness of breath and/or angina. Shifts in NYHA functional classification from baseline over all post-baseline visits will be presented.

    Measured: 90 days and 2 years

  13. Functional Status Change as measured by 6-Minute Walk Test

    Subjects complete a six (6) minute walk test at the study visits described in the study protocol. Total distance walked (meters) will be collected and analyzed by means of descriptive statistics including the absolute value and change from baseline by visit.

    Measured: 90 days and 2 years

Timeline

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

  1. First posted9 Jul 2019
  2. Study start26 Jun 2019
  3. Primary completion30 Oct 2021
  4. Study completionDec 2031 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04012944
Sponsor's protocol ID
ETX-HFS-PA-02
Status last verified
May 2026
First submitted
12 Jun 2019
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
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 III, run by Endotronix, Inc. at 7 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 11 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Germany, 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety: Freedom from Adverse Events (time frame: 30 days). The study lists 2 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 NCT04012944.

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 27 Jul 2026.

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