Status:
COMPLETED
SIRONA Trial Heart Failure NYHA Class III
Lead Sponsor:
Endotronix, Inc.
Conditions:
Heart Failure NYHA Class III
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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-implan...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- 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
- 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
- Subjects with an indwelling inferior vena cava (IVC) filter
- Subjects who are pregnant or breastfeeding
- Subjects whose clinical condition, in the opinion of the Investigator, makes them an unsuitable candidate for the study
- Severe illness, other than heart disease, which would limit survival to \<1 year
- Subjects who have had intractable arrhythmias within 2 month of the Screening Visit
- Subjects with patent foramen ovale (PFO)
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03375710
Start Date
December 1 2017
End Date
August 26 2025
Last Update
September 2 2025
Active Locations (2)
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1
Ziekenhuis Oost Limburg
Genk, Belgium, 3600
2
Galway University Hospital
Galway, Ireland, H91 YR71