SIRONA Trial Heart Failure NYHA Class III

NCT03375710 | Completed DMC

• 1 other identifier: ETX-HFS-PA-01
• Study Type: interventional
• Target: 15
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Heart Failure NYHA Class III

Keywords

Heart Failure; Heart Diseases; Cardiovascular Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Frequency of Adverse Events

  30 days and 2 years

• Device/system-related complications

  30 days and 2 years

• Pressure sensor failure rate

  30 days and 2 years

• Accuracy of Cordella™ sensor pressure measurements

  2 years

• Percentage of device success

  90 days

Study Arms (1)

Cordella™ Heart Failure System

EXPERIMENTAL

Cordella™ Heart Failure System and implant of Cordella™ Pulmonary Artery Sensor System (CorPASS)

Device: Cordella™ Heart Failure System

Interventions

Cordella™ Heart Failure System DEVICE

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)

Cordella™ Heart Failure System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Endotronix, Inc.: lead

Study Sites (2)

Ziekenhuis Oost Limburg

Genk, 3600, Belgium

Location

Galway University Hospital

Galway, H91 YR71, Ireland

Location

MeSH Terms

Conditions

Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Officials

• Andrea Sauerland

  Endotronix, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: December 18, 2017
• Study Start: December 1, 2017
• Primary Completion: May 28, 2019
• Study Completion: August 26, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

IE (1); BE (1)