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Heart Failure NYHA Class IIINCT03375710

SIRONA Trial Heart Failure NYHA Class III

A study testing Cordella™ Heart Failure System in people with Heart Failure NYHA Class III, run by Endotronix, Inc. at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a prospective, multi-center, open-label, single-arm feasibility trial to assess device safety and efficacy of the Cordella™ Heart Failure System in 10 NYHA Class III heart failure patients who will receive the Cordella™ 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™ Heart Failure System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
2 sitesin 2 countries
Study dates
1 Dec 2017to 26 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

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 ≥ 3 months with either preserved or reduced left ventricular ejection fraction (LVEF)
  • Diagnosis of NYHA Class III HF at the time of Screening with at least 1 HF-related hospitalization, HF treatment in a hospital day-care setting, or urgent outpatient clinic HF visit within the last year
  • 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 with a Body Mass Index (BMI) < 35 kg/mL2 and chest circumference < 1050 mm
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  • Subjects with right pulmonary artery branch diameter sized between 14 mm and 20 mm (target Sensor implant site) over a length of at least 30mm
  • Subjects with distance between target implant site (right PA branch) and ventral thoracic skin surface of < 12cm
  • 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
  • Subject compliance as defined by data collection and transmissions at least 5 days a week (does not have to be consecutive days) using the myCordella™ Hub \& Peripherals for at least 1 week during the screening period

Who cannot join

  • Subjects with primary pulmonary hypertension.
  • Subjects with an active infection at the Sensor Implant Visit
  • Subjects with history of recurrent (> 1) 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 or computed tomography pulmonary angiography (CTPA) is contraindicated
  • Subjects with a Cardiac Resynchronization Device (CRT), Internal Cardiac Defibrillator (ICD) or pacemaker (if implanted less than 6 months or has more than a single lead), or Left Ventricular Assist Device (LVAD)
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  • Any major surgery within 30 days of the Sensor Implant Visit.
  • Subjects with a Glomerular Filtration Rate (GFR) <30 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
  • Subjects likely to undergo lung and/ or heart transplantation within 24 months of the Screening Visit.
  • 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
  • Subjects enrolled in another investigational trial.
  • Known history of life threatening allergy to contrast dye.
  • 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
  • Subjects with large metal implants/prostheses or any other materials in the thoracic cavity that may interfere with the Cordella™ Pulmonary Artery Sensor System performance
  • Subjects with an indwelling inferior vena cava (IVC) filter
  • Subjects who are pregnant or breastfeeding
  • Subjects whose clinical condition, in the opinion of the Investigator, makes them an unsuitable candidate for the study
  • Severe illness, other than heart disease, which would limit survival to <1 year
  • Subjects who have had intractable arrhythmias within 2 month of the Screening Visit
  • Subjects with patent foramen ovale (PFO)

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Belgium1 site

  • Ziekenhuis Oost Limburg

    Genk, 3600

Other trials in Belgium

Ireland1 site

  • Galway University Hospital

    Galway, H91 YR71

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™ Heart Failure System in (New York Heart Association) NYHA Class III Heart Failure Patients

This is a prospective, multi-center, open-label, single-arm feasibility trial to assess device safety and efficacy of the Cordella™ Heart Failure System in 10 NYHA Class III heart failure patients who will receive the Cordella™ Sensor implant.

Read the detailed description

The objectives of this study are to establish that the Cordella™ Sensor can be safely delivered, deployed, and remain stable within the target pulmonary artery (PA) segment through 30 days post-implant as well as to measure the accuracy of Cordella™ Sensor PA pressure measurements compared with fluid-filled catheter PA pressure measurements obtained by standard right heart catheterization (RHC) at 90 days post implant. Safety measures will include the frequency and rates of adverse events, both overall and for each specific event, which will be collected throughout the study. Subjects will remain in this trial for 24 months.

Being tested
Cordella™ Heart Failure 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™ Heart Failure SystemDevice

    The Cordella™ Heart Failure System collects, records, and transmits physiologic data and communications from the patient at home to clinicians for assessment, patient communication, and patient-centered heart failure management. The system consists of the following components:

    1. myCordella™ Patient Management Portal
    2. myCordella™ Hub
    3. myCordella™ Peripherals, including the Cordella™ Pulmonary Artery Sensor System (CorPASS)
Study groups in NCT03375710
Study groupRoleWhat they receive
Cordella™ Heart Failure SystemExperimentalCordella™ Heart Failure System and implant of Cordella™ Pulmonary Artery Sensor System (CorPASS)
Receives: Device: Cordella™ Heart Failure System

What is being measured

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

  1. Safety Freedom form Adverse events

    Freedom from adverse events associated with use of the Cordella™ HF System

    Measured: 30 days

  2. Efficacy: Accuracy

    Accuracy of Cordella™ Sensor PA pressure measurements, compared to standard-of-care fluid-filled catheter PA pressure measurements obtained by standard Right Heart Catheter

    Measured: 90 days

Secondary outcomes (10)

  1. Frequency of Adverse Events

    Frequency of adverse events throughout the study

    Measured: 30 days and 2 years

  2. Device/system-related complications

    Device/system-related complications

    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 of Cordella™ sensor pressure measurements

    Accuracy of Cordella™ Sensor PA pressure measurements compared with echo pulmonary artery pressure (PAP) measurements

    Measured: 2 years

  5. Percentage of device success

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

    Measured: 90 days

  6. Change in Pulmonary Artery (PA) pressure

    Change in PA pressure pre- and post-implant

    Measured: 90 days

  7. Heart Failure (HF) Hospitalizations

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

    Measured: 90 days

  8. Quality of Life measured by Kansas City Cardiomyopathy Questionnaire

    Quality of Life measured by KCCQ at 90 days and 2 years post implant procedure

    Measured: 90 days and 2 years

  9. Quality of Life measured by EuroQOL EQ-5D-5L

    Quality of Life measured by EuroQOL EQ-5D-5L at 90 days and 2 years post implant procedure

    Measured: 90 days and 2 years

  10. Adherence to regular myCordella™ Peripherals measurements

    Adherence to regular myCordella™ Peripherals measurements

    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 posted18 Dec 2017
  2. Study start1 Dec 2017
  3. Primary completion28 May 2019
  4. Study completion26 Aug 2025

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
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03375710
Sponsor's protocol ID
ETX-HFS-PA-01
Status last verified
Aug 2025
First submitted
7 Dec 2017
Last updated
2 Sep 2025
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™ Heart Failure System in people with Heart Failure NYHA Class III, run by Endotronix, Inc. at 2 sites in 2 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 13 inclusion and 23 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: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 form 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 NCT03375710.

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 2 Sep 2025.

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