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出境医 / 临床实验 / SIRONA 2 Trial Heart Failure NYHA Class III

SIRONA 2 Trial Heart Failure NYHA Class III

Study Description
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 60 New York Heart Association (NYHA) Class III Heart Failure patients who will receive the Cordella PA Sensor Implant.

Condition or disease Intervention/treatment Phase
Heart Failure NYHA Class III Device: Cordella™ Pulmonary Artery Sensor System Not Applicable

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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)
Actual Study Start Date : June 26, 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : December 2023
Arms and Interventions
Arm Intervention/treatment
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
Device: Cordella™ Pulmonary Artery Sensor System

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).

Outcome Measures
Primary Outcome Measures :
  1. Safety: Freedom from Adverse Events [ Time Frame: 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.

  2. 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 ]
    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 Outcome Measures :
  1. Frequency of Adverse Events [ Time Frame: 30 days and 2 years ]
    Frequency of adverse events throughout the study

  2. Device/system-related complications [ Time Frame: 30 days and 2 years ]
    The rate of device/system-related complications will be assessed throughout the study

  3. Pressure sensor failure rate [ Time Frame: 30 days and 2 years ]
    Pressure sensor failure rate throughout the study

  4. Accuracy using the Bland Altman Method [ Time Frame: 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.

  5. Accuracy of Cordella PA Sensor pressure measurements [ Time Frame: 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

  6. Device Success [ Time Frame: 90 days ]
    Percentage of device success as documented by ability of the System to successfully transmit collected PAP data to a secure database

  7. Change in Pulmonary Artery (PA) pressure [ Time Frame: 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

  8. HF related hospitalizations, treatments in a hospital day-care setting, or urgent outpatient clinic visits. [ Time Frame: 90 days and 2 years ]
    Frequency of HF hospitalizations, HF treatments in a hospital day-care setting, or urgent outpatient clinic HF visits.

  9. Quality of Life measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: 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.

  10. 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 ]
    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.

  11. Heart Failure related medication changes [ Time Frame: 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

  12. Functional Status Change as measured by New York Heart Association (NYHA) functional classification [ Time Frame: 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.

  13. Functional Status Change as measured by 6-Minute Walk Test [ Time Frame: 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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Sladjana Nincic +49 160 979 24095 sladjana.nincic@endotronix.com

Locations
Layout table for location information
Belgium
Cardivascular Center OLV Aalst Recruiting
Aalst, Belgium
Contact: Dr. Jozef Bartunek         
Ziekenhuis- Oost Limburg Recruiting
Genk, Belgium
Contact: Prof. Wilfried Mullens         
Germany
Uniklinik Köln, Klinik III für Innere Medizin Herzzentrum der Universität zu Köln Recruiting
Cologne, Germany
Contact: Prof. Stephan Rosenkranz         
Universitätsklinikum Giessen und Marburg GmbH, Standort Giessen Medizinische Klinik I, Abteilung Kardiologie und Angiologie Recruiting
Gießen, Germany, 35392
Contact: Prof. Birgit Assmus         
Klinik für Kardiologie und Angiologie/ Studienambulanz Medizinische Hochschule Hannover (MHH) Recruiting
Hannover, Germany, 30625
Contact: Prof. Tibor Kempf         
Ireland
Mater Misericordiae University Hospital Recruiting
Dublin, Ireland
Contact: Prof. Niall Mahon         
University Hospital Galway Recruiting
Dublin, Ireland
Contact: Dr. Faisal Sharif         
Sponsors and Collaborators
Endotronix, Inc.
Investigators
Layout table for investigator information
Study Director: Andrea Sauerland Endotronix, Inc.
Tracking Information
First Submitted Date  ICMJE June 12, 2019
First Posted Date  ICMJE July 9, 2019
Last Update Posted Date February 4, 2021
Actual Study Start Date  ICMJE June 26, 2019
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • Safety: Freedom from Adverse Events [ Time Frame: 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) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • Frequency of Adverse Events [ Time Frame: 30 days and 2 years ]
    Frequency of adverse events throughout the study
  • Device/system-related complications [ Time Frame: 30 days and 2 years ]
    The rate of device/system-related complications will be assessed throughout the study
  • Pressure sensor failure rate [ Time Frame: 30 days and 2 years ]
    Pressure sensor failure rate throughout the study
  • Accuracy using the Bland Altman Method [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SIRONA 2 Trial Heart Failure NYHA Class III
Official Title  ICMJE 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)
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 60 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Heart Failure NYHA Class III
Intervention  ICMJE Device: Cordella™ Pulmonary Artery Sensor System

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).
Study Arms  ICMJE 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
Intervention: Device: Cordella™ Pulmonary Artery Sensor System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 8, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sladjana Nincic +49 160 979 24095 sladjana.nincic@endotronix.com
Listed Location Countries  ICMJE Belgium,   Germany,   Ireland
Removed Location Countries United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT04012944
Other Study ID Numbers  ICMJE ETX-HFS-PA-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Endotronix, Inc.
Study Sponsor  ICMJE Endotronix, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Andrea Sauerland Endotronix, Inc.
PRS Account Endotronix, Inc.
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP