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: 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
81
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).
Cardivascular Center OLV Aalst
Aalst, Belgium
Ziekenhuis- Oost Limburg
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
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.
Time frame: 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.
Time frame: 90 days
Frequency of Adverse Events
Frequency of adverse events throughout the study
Time frame: 30 days and 2 years
Device/system-related complications
The rate of device/system-related complications will be assessed throughout the study
Time frame: 30 days and 2 years
Pressure sensor failure rate
Pressure sensor failure rate throughout the study
Time frame: 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.
Time frame: 90 days
Accuracy of Cordella PA Sensor pressure measurements
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Klinik für Kardiologie und Angiologie/ Studienambulanz Medizinische Hochschule Hannover (MHH)
Hanover, Germany
Mater Misericordiae University Hospital
Dublin, Ireland
University Hospital Galway
Dublin, Ireland
Accuracy of Cordella PA Sensor System pressure measurements, compared to standard-of-care fluid-filled catheter PA pressure measurements obtained by standard RHC
Time frame: 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
Time frame: 90 days
Change in Pulmonary Artery (PA) pressure
Change in PA pressure: 1. Pre- and post-implant 2. Before and after 6-Minute Walk Test 3. Sitting vs supine PA pressure measurements
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 90 days and 2 years