SIRONA Trial Heart Failure NYHA Class III

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: Completed
• Conditions: Heart Failure NYHA Class III
• Intervention / Treatment: Device: Cordella™ Heart Failure System

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: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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: myCordella™ Patient Management Portal; myCordella™ Hub; myCordella™ Peripherals, including the Cordella™ Pulmonary Artery Sensor System (CorPASS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Freedom form Adverse events	Freedom from adverse events associated with use of the Cordella™ HF System	30 days
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	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Adverse Events	Frequency of adverse events throughout the study	30 days and 2 years
Device/system-related complications	Device/system-related complications	30 days and 2 years
Pressure sensor failure rate	Pressure sensor failure rate throughout the study	30 days and 2 years
Accuracy of Cordella™ sensor pressure measurements	Accuracy of Cordella™ Sensor PA pressure measurements compared with echo pulmonary artery pressure (PAP) measurements	2 years
Percentage of device success	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	Change in PA pressure pre- and post-implant	90 days
Heart Failure (HF) Hospitalizations	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	Adherence to regular myCordella™ Peripherals measurements	90 days and 2 years
Quality of Life measured by Kansas City Cardiomyopathy Questionnaire	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	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

• Sponsor: Endotronix, Inc.
• Investigators: Study Director: Andrea Sauerland, Endotronix, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): May 28, 2019
• Study Completion (Actual): August 26, 2025

Study Registration Dates

• First Submitted: December 7, 2017
• First Submitted That Met QC Criteria: December 12, 2017
• First Posted (Actual): December 18, 2017

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Heart Failure; Cardiovascular Disease; Heart Diseases
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; Cardiovascular Diseases; Heart Diseases
• Other Study ID 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