- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04012944
SIRONA 2 Trial Heart Failure NYHA Class III
A Prospective, Multi-Center, Open-Label, Single-Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class III Heart Failure Patients (SIRONA 2 Trial)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study objectives are:
- 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.
- 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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Aalst, Belgium
- Cardivascular Center OLV Aalst
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Antwerp, Belgium
- ZNA Middelheim
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Genk, Belgium
- Ziekenhuis- Oost Limburg
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Cologne, Germany
- Uniklinik Köln, Klinik III für Innere Medizin Herzzentrum der Universität zu Köln
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Gießen, Germany
- Universitätsklinikum Giessen und Marburg GmbH, Standort Giessen Medizinische Klinik I, Abteilung Kardiologie und Angiologie
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Hannover, Germany
- Klinik für Kardiologie und Angiologie/ Studienambulanz Medizinische Hochschule Hannover (MHH)
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Dublin, Ireland
- Mater Misericordiae University Hospital
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Dublin, Ireland
- University Hospital Galway
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 with LVEF ≤ 40%: NT-proBNP ≥ 1000 pg/mL (or BNP ≥ 250 pg/mL).
- 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
- 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:
- Subjects with primary pulmonary hypertension
- Subjects with an active infection at the Cordella PA Sensor Implant Visit
- Subjects with history of 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 is contraindicated
- 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
- Any major surgery within 30 days of the Sensor Implant Visit.
- Subjects with a Glomerular Filtration Rate (GFR) <25 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
- Received or are likely to receive an advanced therapy (e.g., mechanical circulatory support or lung or heart transplant) in the next 12 months
- 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
- Known history of life threatening allergy to contrast dye
- Subjects who are pregnant or breastfeeding
- 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
- Severe illness, other than heart disease, which would limit survival to <1 year
- Subjects whose clinical condition, in the opinion of the Investigator, makes them an unsuitable candidate for the study
- Subjects enrolled in another investigational trial with an active Treatment Arm
- Subject who is in custody by order of an authority or a court of law
- Unrepaired severe valvular disease
- Subjects with an inferior vena cava (IVC) filter
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Cordella™ Pulmonary Artery Sensor System
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
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Safety: Freedom from Adverse Events
Time Frame: 30 days
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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.
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30 days
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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)
Time Frame: 90 days
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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.
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90 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Frequency of Adverse Events
Time Frame: 30 days and 2 years
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Frequency of adverse events throughout the study
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30 days and 2 years
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Pressure sensor failure rate
Time Frame: 30 days and 2 years
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Pressure sensor failure rate throughout the study
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30 days and 2 years
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Device/system-related complications
Time Frame: 30 days and 2 years
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The rate of device/system-related complications will be assessed throughout the study
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30 days and 2 years
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Accuracy using the Bland Altman Method
Time Frame: 90 days
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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.
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90 days
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Accuracy of Cordella PA Sensor pressure measurements
Time Frame: 12 months
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Accuracy of Cordella PA Sensor System pressure measurements, compared to standard-of-care fluid-filled catheter PA pressure measurements obtained by standard RHC
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12 months
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Device Success
Time Frame: 90 days
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Percentage of device success as documented by ability of the System to successfully transmit collected PAP data to a secure database
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90 days
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Change in Pulmonary Artery (PA) pressure
Time Frame: 90 days and 2 years
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Change in PA pressure:
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90 days and 2 years
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HF related hospitalizations, treatments in a hospital day-care setting, or urgent outpatient clinic visits.
Time Frame: 90 days and 2 years
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Frequency of HF hospitalizations, HF treatments in a hospital day-care setting, or urgent outpatient clinic HF visits.
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90 days and 2 years
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Quality of Life measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: 90 days and 2 years
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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.
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90 days and 2 years
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Adherence to regular myCordella™ Peripherals measurements measured as a percentage of subjects who adhere to regular myCordella™ Peripherals measurements
Time Frame: 90 days and 2 years
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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.
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90 days and 2 years
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Heart Failure related medication changes
Time Frame: 90 days and 2 years
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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
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90 days and 2 years
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Functional Status Change as measured by New York Heart Association (NYHA) functional classification
Time Frame: 90 days and 2 years
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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.
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90 days and 2 years
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Functional Status Change as measured by 6-Minute Walk Test
Time Frame: 90 days and 2 years
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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.
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90 days and 2 years
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Andrea Sauerland, Endotronix, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ETX-HFS-PA-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Failure NYHA Class III
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Vanderbilt University Medical CenterWithdrawnHeart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure NYHA Class IUnited States
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University of MichiganNational Heart, Lung, and Blood Institute (NHLBI)RecruitingHeart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure NYHA Class IVUnited States
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Comunicare Solutions SAKU Leuven; Jessa Hospital; Cliniques universitaires Saint-Luc- Université Catholique... and other collaboratorsRecruitingHeart Failure | Heart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure NYHA Class IVBelgium
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Massachusetts General HospitalRecruitingHeart Failure | Heart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure NYHA Class IUnited States
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Indiana UniversityCompletedHeart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure NYHA Class IUnited States
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Elpen Pharmaceutical Co. Inc.WithdrawnHeart Failure | Heart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure NYHA Class IV
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University Hospital, Gentofte, CopenhagenUnknownChronic Heart Failure | Heart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure NYHA Class IVDenmark
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John ParissisCompletedHeart Failure | Heart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure NYHA Class IV | Heart Failure NYHA Class IGreece
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Alexandria UniversityCompletedHeart Failure | Heart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure With Reduced Ejection Fraction | Heart Failure NYHA Class IVEgypt
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Endotronix, Inc.RecruitingHeart Failure NYHA Class II | Heart Failure NYHA Class IIIUnited States
Clinical Trials on Cordella™ Pulmonary Artery Sensor System
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Endotronix, Inc.Active, not recruitingHeart Failure NYHA Class IIIUnited States, Ireland, Belgium
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Endotronix, Inc.RecruitingHeart Failure NYHA Class II | Heart Failure NYHA Class IIIUnited States
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Endotronix, Inc.TerminatedHeart Failure NYHA Class IIIUnited States
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Endotronix, Inc.Active, not recruiting
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IHF GmbH - Institut für HerzinfarktforschungRecruiting
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ActiViews Ltd.Completed
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Medtronic DiabetesCompletedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
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Abbott Medical DevicesCompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure With Reduced Ejection Fraction | Heart Failure NYHA Class IV | Heart Failure With Normal Ejection Fraction | Heart Failure; With Decompensation | Heart Failure...United States, Canada
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Aymen N NaguibCompletedTetralogy of Fallot | Pulmonary Atresia | Pulmonary Artery StenosisUnited States