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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.
The study objectives are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cordella™ Pulmonary Artery Sensor System | Experimental | The Cordella PA Sensor System (CorPASS) is intended to measure, record, and transmit pulmonary artery pressure (PAP) data from NYHA Class III heart failure patients at home to clinicians for assessment and patient-centered heart failure management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cordella™ Pulmonary Artery Sensor System | Device | 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.
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Freedom from Adverse Events | 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. | 30 days |
| 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) | 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. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Adverse Events | Frequency of adverse events throughout the study | 30 days and 2 years |
| Device/system-related complications | The rate of device/system-related complications will be assessed throughout the study |
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Inclusion Criteria:
Subject has given written informed consent
Male or female, at least 18 years of age
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
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:
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 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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward Karst | Edwards Lifesciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardivascular Center OLV Aalst | Aalst | Belgium | ||||
| Ziekenhuis- Oost Limburg |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| 30 days and 2 years |
| Pressure sensor failure rate | Pressure sensor failure rate throughout the study | 30 days and 2 years |
| Accuracy using the Bland Altman Method | 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. | 90 days |
| Accuracy of Cordella PA Sensor pressure measurements | Accuracy of Cordella PA Sensor System pressure measurements, compared to standard-of-care fluid-filled catheter PA pressure measurements obtained by standard RHC | 12 months |
| Device Success | Percentage of device success as documented by ability of the System to successfully transmit collected PAP data to a secure database | 90 days |
| Change in Pulmonary Artery (PA) pressure | Change in PA pressure:
| 90 days and 2 years |
| HF related hospitalizations, treatments in a hospital day-care setting, or urgent outpatient clinic visits. | Frequency of HF hospitalizations, HF treatments in a hospital day-care setting, or urgent outpatient clinic HF visits. | 90 days and 2 years |
| Quality of Life measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) | 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. | 90 days and 2 years |
| Adherence to regular myCordella™ Peripherals measurements measured as a percentage of subjects who adhere to regular myCordella™ Peripherals measurements | 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. | 90 days and 2 years |
| Heart Failure related medication changes | 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 | 90 days and 2 years |
| Functional Status Change as measured by New York Heart Association (NYHA) functional classification | 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. | 90 days and 2 years |
| Functional Status Change as measured by 6-Minute Walk Test | 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. | 90 days and 2 years |
| Genk |
| Belgium |
| Uniklinik Köln, Klinik III für Innere Medizin Herzzentrum der Universität zu Köln | Cologne | Germany |
| Universitätsklinikum Giessen und Marburg GmbH, Standort Giessen Medizinische Klinik I, Abteilung Kardiologie und Angiologie | Giessen | Germany |
| Klinik für Kardiologie und Angiologie/ Studienambulanz Medizinische Hochschule Hannover (MHH) | Hanover | Germany |
| Mater Misericordiae University Hospital | Dublin | Ireland |
| University Hospital Galway | Dublin | Ireland |