SIRONA Trial Heart Failure NYHA Class III

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Heart Failure NYHA Class III

Intervention / Treatment
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* Device: Cordella™ Heart Failure System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cordella™ Heart Failure System<br>Cordella™ Heart Failure System and implant of Cordella™ Pulmonary Artery Sensor System (CorPASS) | Device: Cordella™ Heart Failure System<br>* 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)<br>|

What is the study measuring?
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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 | 
| Quality of Life | Quality of Life measured by KCCQ | 90 days and 2 years | 
| Quality of Life | Quality of Life measured by EuroQOL EQ-5D-5L | 90 days and 2 years | 
| Adherence to regular myCordella™ Peripherals measurements | Adherence to regular myCordella™ Peripherals measurements | 90 days and 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Heart Diseases, Cardiovascular Disease