SIRONA 2 Trial Heart Failure NYHA Class III

NCT04012944 | Active Not Recruiting DMC

• 1 other identifier: ETX-HFS-PA-02
• Study Type: interventional
• Target: 81
• Locations: 3 countries
• Sites: 7

Brief 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.

Conditions

Heart Failure NYHA Class III

Keywords

Heart Failure; Heart Diseases; Cardiovascular Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  30 days

• 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.

  90 days

Secondary Outcomes (13)

• 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 using the Bland Altman Method

  90 days

• Accuracy of Cordella PA Sensor pressure measurements

  12 months

Study Arms (1)

Cordella™ Pulmonary Artery Sensor System

EXPERIMENTAL

The 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

Device: Cordella™ Pulmonary Artery Sensor System

Interventions

Cordella™ Pulmonary Artery Sensor System DEVICE

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).

Cordella™ Pulmonary Artery Sensor 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 ≥ 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Endotronix, Inc.: lead

Study Sites (7)

Cardivascular Center OLV Aalst

Aalst, Belgium

Location

Ziekenhuis- Oost Limburg

Genk, Belgium

Location

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

Cologne, Germany

Location

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

Giessen, Germany

Location

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

Hanover, Germany

Location

Mater Misericordiae University Hospital

Dublin, Ireland

Location

University Hospital Galway

Dublin, 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: June 12, 2019
• First Posted: July 9, 2019
• Study Start: June 26, 2019
• Primary Completion: October 30, 2021
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 7, 2025

Record last verified: 2025-08

Locations

DE (3); IE (2); BE (2)