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SIRONA Trial Heart Failure NYHA Class III

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ClinicalTrials.gov Identifier: NCT03375710
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
Endotronix, Inc.

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.

Condition or disease Intervention/treatment Phase
Heart Failure NYHA Class III Device: Cordella™ Heart Failure System Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : September 27, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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:

  1. myCordella™ Patient Management Portal
  2. myCordella™ Hub
  3. myCordella™ Peripherals, including the Cordella™ Pulmonary Artery Sensor System (CorPASS)




Primary Outcome Measures :
  1. Safety Freedom form Adverse events [ Time Frame: 30 days ]
    Freedom from adverse events associated with use of the Cordella™ HF System

  2. 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


Secondary Outcome Measures :
  1. Frequency of Adverse Events [ Time Frame: 30 days and 2 years ]
    Frequency of adverse events throughout the study

  2. Device/system-related complications [ Time Frame: 30 days and 2 years ]
    Device/system-related complications

  3. Pressure sensor failure rate [ Time Frame: 30 days and 2 years ]
    Pressure sensor failure rate throughout the study

  4. 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

  5. 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

  6. Change in Pulmonary Artery (PA) pressure [ Time Frame: 90 days ]
    Change in PA pressure pre- and post-implant

  7. 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.

  8. Quality of Life [ Time Frame: 90 days and 2 years ]
    Quality of Life measured by KCCQ

  9. Quality of Life [ Time Frame: 90 days and 2 years ]
    Quality of Life measured by EuroQOL EQ-5D-5L

  10. Adherence to regular myCordella™ Peripherals measurements [ Time Frame: 90 days and 2 years ]
    Adherence to regular myCordella™ Peripherals measurements



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03375710


Contacts
Contact: Andrea Sauerland +1 630 599 7176 andrea.sauerland@endotronix.com

Locations
Belgium
Ziekenhuis Oost Limburg Recruiting
Genk, Belgium, 3600
Ireland
Galway University Hospital Recruiting
Galway, Ireland, H91 YR71
Sponsors and Collaborators
Endotronix, Inc.
Investigators
Study Director: Andrea Sauerland Endotronix, Inc.

Responsible Party: Endotronix, Inc.
ClinicalTrials.gov Identifier: NCT03375710     History of Changes
Other Study ID Numbers: ETX-HFS-PA-01
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Endotronix, Inc.:
Heart Failure
Heart Diseases
Cardiovascular Disease

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases