Heart Failure NYHA Class III
Conditions
Keywords
Heart Failure, Heart Diseases, Cardiovascular Disease
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.
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.
Interventions
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)
Sponsors
Endotronix, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Freedom form Adverse events | 30 days | Freedom from adverse events associated with use of the Cordella™ HF System |
| Efficacy: Accuracy | 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
| Measure | Time frame | Description |
|---|---|---|
| Pressure sensor failure rate | 30 days and 2 years | Pressure sensor failure rate throughout the study |
| Accuracy of Cordella™ sensor pressure measurements | 2 years | Accuracy of Cordella™ Sensor PA pressure measurements compared with echo pulmonary artery pressure (PAP) measurements |
| Percentage of device success | 90 days | Percentage of device success as documented by ability of the System to successfully transmit collected data to a secure database |
| Change in Pulmonary Artery (PA) pressure | 90 days | Change in PA pressure pre- and post-implant |
| Frequency of Adverse Events | 30 days and 2 years | Frequency of adverse events throughout the study |
| Quality of Life measured by Kansas City Cardiomyopathy Questionnaire | 90 days and 2 years | Quality of Life measured by KCCQ at 90 days and 2 years post implant procedure |
| Quality of Life measured by EuroQOL EQ-5D-5L | 90 days and 2 years | Quality of Life measured by EuroQOL EQ-5D-5L at 90 days and 2 years post implant procedure |
| Adherence to regular myCordella™ Peripherals measurements | 90 days and 2 years | Adherence to regular myCordella™ Peripherals measurements |
| Heart Failure (HF) Hospitalizations | 90 days | Frequency of HF hospitalizations, HF treatments in a hospital day-care setting, or urgent outpatient clinic HF visits. |
| Device/system-related complications | 30 days and 2 years | Device/system-related complications |
Countries
Belgium, Ireland
Outcome results
None listed