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 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.
Detailed description
The study objectives are: 1. To establish that the Cordella PA Sensor can be safely delivered, deployed, and remain stable within the target pulmonary artery (PA) segment through 30 days post-implant. 2. To compare Cordella PA Sensor System pressure measurements with fluid-filled catheter PA pressure measurements obtained by standard right heart catheterization (RHC) at 90 days post implant.
Interventions
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).
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 ≥ 6 months with either preserved or reduced left ventricular ejection fraction (LVEF) and NYHA Class III HF at the time of Screening 4. 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: 1. Subjects with LVEF ≤ 40%: NT-proBNP ≥ 1000 pg/mL (or BNP ≥ 250 pg/mL). 2. 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 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 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 7. 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 8. Subject has sufficient Cellular and/or Wi- Fi Internet coverage at home 9. Subject agrees to return to the treating Investigator for all scheduled follow up visits and can return to the hospital for follow up
Exclusion criteria
1. Subjects with primary pulmonary hypertension 2. Subjects with an active infection at the Cordella PA Sensor Implant Visit 3. Subjects with history of 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 is contraindicated 6. 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 7. Any major surgery within 30 days of the Sensor Implant Visit. 8. Subjects with a Glomerular Filtration Rate (GFR) \<25 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. Received or are likely to receive an advanced therapy (e.g., mechanical circulatory support or lung or heart transplant) in the next 12 months 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. Known history of life threatening allergy to contrast dye 15. Subjects who are pregnant or breastfeeding 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. Severe illness, other than heart disease, which would limit survival to \<1 year 18. Subjects whose clinical condition, in the opinion of the Investigator, makes them an unsuitable candidate for the study 19. Subjects enrolled in another investigational trial with an active Treatment Arm 20. Subject who is in custody by order of an authority or a court of law 21. Unrepaired severe valvular disease 22. Subjects with an inferior vena cava (IVC) filter
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Freedom from Adverse Events | 30 days | 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. |
| 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) | 90 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Adverse Events | 30 days and 2 years | Frequency of adverse events throughout the study |
| Device/system-related complications | 30 days and 2 years | The rate of device/system-related complications will be assessed throughout the study |
| Pressure sensor failure rate | 30 days and 2 years | Pressure sensor failure rate throughout the study |
| Accuracy using the Bland Altman Method | 90 days | Accuracy of Cordella PA Sensor System pressure measurements, compared to standard-of-care fluid-filled catheter PA pressure measurements obtained by standard RHC using the Bland Altman method. |
| Accuracy of Cordella PA Sensor pressure measurements | 12 months | Accuracy of Cordella PA Sensor System pressure measurements, compared to standard-of-care fluid-filled catheter PA pressure measurements obtained by standard RHC |
| Device Success | 90 days | Percentage of device success as documented by ability of the System to successfully transmit collected PAP data to a secure database |
| Change in Pulmonary Artery (PA) pressure | 90 days and 2 years | Change in PA pressure: 1. Pre- and post-implant 2. Before and after 6-Minute Walk Test 3. Sitting vs supine PA pressure measurements |
| HF related hospitalizations, treatments in a hospital day-care setting, or urgent outpatient clinic visits. | 90 days and 2 years | Frequency of HF hospitalizations, HF treatments in a hospital day-care setting, or urgent outpatient clinic HF visits. |
| Quality of Life measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) | 90 days and 2 years | The Quality of Life KCCQ questionnaire is a measure of health-related quality of life. It is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life related to Heart Failure. Out of 23-items, 10 scores will be calculated: Physical Limitation, Symptom Stability, Symptom Frequency, Symptom Burden, Total Symptom Score, Self-Efficacy, Quality of Life, Social Limitation, Overall Summary Score, Clinical Summary Score .Presentation will be done by means of descriptive statistics including the absolute value and change from baseline by visit. |
| Adherence to regular myCordella™ Peripherals measurements measured as a percentage of subjects who adhere to regular myCordella™ Peripherals measurements | 90 days and 2 years | Subjects will be instructed to perform daily measurements throughout the study. Subject compliance will be defined as at least 5 days of data collection/transmissions per week. |
| Heart Failure related medication changes | 90 days and 2 years | Heart failure related medication change will be collected and summarized by visit presenting the percentage of subjects with and without any change in Heart Failure related medication |
| Functional Status Change as measured by New York Heart Association (NYHA) functional classification | 90 days and 2 years | The NYHA functional classification categorizes the extent of heart failure by placing subjects in one of four (I, II, III, IV) categories based on how much they are limited during physical activity and symptoms of shortness of breath and/or angina. Shifts in NYHA functional classification from baseline over all post-baseline visits will be presented. |
| Functional Status Change as measured by 6-Minute Walk Test | 90 days and 2 years | Subjects complete a six (6) minute walk test at the study visits described in the study protocol. Total distance walked (meters) will be collected and analyzed by means of descriptive statistics including the absolute value and change from baseline by visit. |
Countries
Belgium, Germany, Ireland
Contacts
STUDY_DIRECTOREdward Karst
Edwards Lifesciences
Outcome results
None listed