SIRONA Trial Heart Failure NYHA Class III

August 25, 2025 updated by: Endotronix, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Genk, Belgium, 3600
        • Ziekenhuis Oost Limburg
  • Ireland
      • Galway, Ireland, H91 YR71
        • Galway University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subject has given written informed consent
  2. Male or female, at least 18 years of age
  3. Diagnosis of HF ≥ 3 months with either preserved or reduced left ventricular ejection fraction (LVEF)
  4. 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
  5. 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
  6. Subjects with a Body Mass Index (BMI) < 35 kg/mL2 and chest circumference < 1050 mm
  7. 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
  8. Subjects with distance between target implant site (right PA branch) and ventral thoracic skin surface of < 12cm
  9. 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
  10. 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.
  11. Subject has sufficient Cellular and/ or Wi- Fi Internet coverage at home
  12. Subject agrees to return to the treating Investigator for all scheduled follow up visits and can return to the hospital for follow up
  13. 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

Exclusion Criteria:

  1. Subjects with primary pulmonary hypertension.
  2. Subjects with an active infection at the Sensor Implant Visit
  3. Subjects with history of recurrent (> 1) pulmonary embolism or deep vein thrombosis
  4. Subjects who have had a major cardiovascular event (e.g., myocardial infarction, stroke) within 2 months of the Screening Visit
  5. Subjects whereby RHC or computed tomography pulmonary angiography (CTPA) is contraindicated
  6. 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)
  7. Any major surgery within 30 days of the Sensor Implant Visit.
  8. Subjects with a Glomerular Filtration Rate (GFR) <30 ml/min or who are on chronic renal dialysis
  9. Specific liver enzymes [Aspartate Aminotransferase (AST) (SGOT), and Alanine Aminotransferase (ALT) (SGPT) >3 times the upper limit of normal
  10. Subjects likely to undergo lung and/ or heart transplantation within 24 months of the Screening Visit.
  11. Subjects with congenital heart disease or mechanical/tissue right heart valve(s)
  12. Subjects with known coagulation disorders
  13. 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
  14. Subjects enrolled in another investigational trial.
  15. Known history of life threatening allergy to contrast dye.
  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. 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
  18. Subjects with an indwelling inferior vena cava (IVC) filter
  19. Subjects who are pregnant or breastfeeding
  20. Subjects whose clinical condition, in the opinion of the Investigator, makes them an unsuitable candidate for the study
  21. Severe illness, other than heart disease, which would limit survival to <1 year
  22. Subjects who have had intractable arrhythmias within 2 month of the Screening Visit
  23. Subjects with patent foramen ovale (PFO)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cordella™ Heart Failure System
Cordella™ Heart Failure System and implant of Cordella™ Pulmonary Artery Sensor System (CorPASS)
Device: Cordella™ Heart Failure System

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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety Freedom form Adverse events
Time Frame: 30 days
Freedom from adverse events associated with use of the Cordella™ HF System
30 days
Efficacy: Accuracy
Time Frame: 90 days
Accuracy of Cordella™ Sensor PA pressure measurements, compared to standard-of-care fluid-filled catheter PA pressure measurements obtained by standard Right Heart Catheter
90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Frequency of Adverse Events
Time Frame: 30 days and 2 years
Frequency of adverse events throughout the study
30 days and 2 years
Device/system-related complications
Time Frame: 30 days and 2 years
Device/system-related complications
30 days and 2 years
Pressure sensor failure rate
Time Frame: 30 days and 2 years
Pressure sensor failure rate throughout the study
30 days and 2 years
Accuracy of Cordella™ sensor pressure measurements
Time Frame: 2 years
Accuracy of Cordella™ Sensor PA pressure measurements compared with echo pulmonary artery pressure (PAP) measurements
2 years
Percentage of device success
Time Frame: 90 days
Percentage of device success as documented by ability of the System to successfully transmit collected data to a secure database
90 days
Change in Pulmonary Artery (PA) pressure
Time Frame: 90 days
Change in PA pressure pre- and post-implant
90 days
Heart Failure (HF) Hospitalizations
Time Frame: 90 days
Frequency of HF hospitalizations, HF treatments in a hospital day-care setting, or urgent outpatient clinic HF visits.
90 days
Adherence to regular myCordella™ Peripherals measurements
Time Frame: 90 days and 2 years
Adherence to regular myCordella™ Peripherals measurements
90 days and 2 years
Quality of Life measured by Kansas City Cardiomyopathy Questionnaire
Time Frame: 90 days and 2 years
Quality of Life measured by KCCQ at 90 days and 2 years post implant procedure
90 days and 2 years
Quality of Life measured by EuroQOL EQ-5D-5L
Time Frame: 90 days and 2 years
Quality of Life measured by EuroQOL EQ-5D-5L at 90 days and 2 years post implant procedure
90 days and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Endotronix, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Andrea Sauerland, Endotronix, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 28, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 26, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ETX-HFS-PA-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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