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Trial record 1 of 1 for:    NCT04089059
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PROACTIVE-HF IDE Trial Heart Failure NYHA Class III (PROACTIVE-HF)

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ClinicalTrials.gov Identifier: NCT04089059
Recruitment Status : Recruiting
First Posted : September 13, 2019
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Endotronix, Inc.

Tracking Information
First Submitted Date  ICMJE August 30, 2019
First Posted Date  ICMJE September 13, 2019
Last Update Posted Date May 12, 2020
Actual Study Start Date  ICMJE January 10, 2020
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2019)
  • Mortality and HF Hospitalizations or Emergency Department/ Hospital Outpatient IV diuretic visits. [ Time Frame: 12 months ]
    Rate of mortality and HF Hospitalizations or Emergency Department/ Hospital Outpatient IV diuretic visits. The rate in each arm is calculated as the total number of observed events in each arm divided by the total observed exposure time in each arm from randomization through 12 months.
  • Safety: Device/system related complication [ Time Frame: 12 months ]
    Freedom from device/system related complication at 12 months
  • Safety: Pressure sensor failure [ Time Frame: 12 months ]
    Freedom from pressure sensor failure at 12 months
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2019)
  • HF Hospitalizations [ Time Frame: 6 months and 12 months ]
    Number of HF Hospitalizations at 6 and 12 months post-implant compared to the number of HF Hospitalizations in the 6 and 12 months prior to implant
  • HF Hospitalizations, Emergency Department/ Hospital Outpatient IV diuretic visits and all-cause mortality [ Time Frame: 6 months ]
    Combined outcome of
    1. First and recurrent HF Hospitalizations
    2. Emergency Department/ Hospital Outpatient IV diuretic visits
    3. all-cause mortality
    at 6 months, added together with equal weighting into a total number of events.
  • Heart failure hospitalization or Emergency Department / Hospital Outpatient IV diuretic visits [ Time Frame: 6 months and 12 months ]
    Heart failure hospitalization or Emergency Department / Hospital Outpatient IV diuretic visits at 6 and 12 months
  • Mortality [ Time Frame: 3 years ]
    Cardiac and all-cause mortality
  • IV diuretic visits [ Time Frame: 3 years ]
    Intravenous (IV) diuretic visits
  • Medication changes [ Time Frame: 3 years ]
    Heart failure related Medication changes will be collected and summarized by visit presenting the percentage of subjects with and without any change in Heart Failure related medication
  • Pulmonary Artery Pressure (PAP) I [ Time Frame: 3 years ]
    Change in Pulmonary Artery Pressure (PAP) from Baseline
  • Pulmonary Artery Pressure (PAP) II [ Time Frame: 3 years ]
    Change in Pulmonary Artery Pressure (PAP) before and after 6-Minute Walk Test
  • Pulmonary Artery Pressure (PAP) III [ Time Frame: 3 years ]
    Change in Pulmonary Artery Pressure (PAP) for patients blinded (12 month) vs patients unblinded (12 month) to PAP measurements
  • Device success [ Time Frame: 3 years ]
    Percentage of device success as documented by ability of the System to successfully transmit PAP data to a secure database
  • KCCQ [ Time Frame: 3 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.
  • NYHA [ Time Frame: 3 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
  • NYHA and 6-Minute Walk Test [ Time Frame: 3 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 . 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
  • Pressure sensor failure [ Time Frame: 3 years ]
    Pressure sensor failure rate throughout the study
  • Serious adverse events [ Time Frame: 3 years ]
    Frequency of serious adverse events throughout the study
Original Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2019)
  • HF Hospitalizations [ Time Frame: 6 months and 12 months ]
    Number of HF Hospitalizations at 6 and 12 months post-implant compared to the number of HF Hospitalizations in the 6 and 12 months prior to implant
  • HF Hospitalizations, Emergency Department/ Hospital Outpatient IV diuretic visits and all-cause mortality [ Time Frame: 6 months ]
    Combined outcome of
    1. First and recurrent HF Hospitalizations
    2. Emergency Department/ Hospital Outpatient IV diuretic visits
    3. all-cause mortality
    at 6 months, added together with equal weighting into a total number of events.
  • Heart failure hospitalization or Emergency Department / Hospital Outpatient IV diuretic visits [ Time Frame: 6 months and 12 months ]
    Heart failure hospitalization or Emergency Department / Hospital Outpatient IV diuretic visits at 6 and 12 months
  • Mortality [ Time Frame: 3 years ]
    Cardiac and all-cause mortality
  • IV diuretic visits [ Time Frame: 3 years ]
    Intravenous (IV) diuretic visits
  • Medication changes [ Time Frame: 3 years ]
    Heart failure related Medication changes will be collected and summarized by visit presenting the percentage of subjects with and without any change in Heart Failure related medication
  • PAP I [ Time Frame: 3 years ]
    Change in PAP from Baseline
  • PAP II [ Time Frame: 3 years ]
    Change in PAP before and after 6-Minute Walk Test
  • PAP III [ Time Frame: 3 years ]
    Change in PAP for patients blinded (12 month) vs patients unblinded (12 month) to PAP measurements
  • Device success [ Time Frame: 3 years ]
    Percentage of device success as documented by ability of the System to successfully transmit PAP data to a secure database
  • KCCQ [ Time Frame: 3 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.
  • NYHA [ Time Frame: 3 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
  • NYHA and 6-Minute Walk Test [ Time Frame: 3 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 . 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
  • Pressure sensor failure [ Time Frame: 3 years ]
    Pressure sensor failure rate throughout the study
  • Serious adverse events [ Time Frame: 3 years ]
    Frequency of serious adverse events throughout the study
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PROACTIVE-HF IDE Trial Heart Failure NYHA Class III
Official Title  ICMJE A Prospective, Multi-Center, Randomized, Controlled, Single Blind 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
Brief Summary This is a prospective, randomized, controlled, single blind, multicenter clinical trial to evaluate the safety and effectiveness of the Cordella PA Sensor System in NYHA Class III Heart Failure Patients
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Condition  ICMJE Heart Failure NYHA Class III
Intervention  ICMJE Device: 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 and comprises of 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
  • Treatment Arm
    Pulmonary Artery Pressure Guided Heart Failure Management (PAPGHFM) and Guideline Directed Medical Therapy (GDMT) considering daily Pulmonary Artery Pressure (PAP) measurements and vital signs collected by Cordella Heart Failure System (CHFS).
    Intervention: Device: Cordella™ Pulmonary Artery Sensor System
  • Control Arm

    Proactive subject management according to GDMT leveraging also the vital signs collected by CHFS.

    After month 12 all data (including PAP measurements) will be available for both the subject and the clinician and the clinician will then treat the subject's HF per PAPGHFM and GDMT considering daily PAP measurements and the vital signs collected by CHFS.

    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: September 11, 2019)
970
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2024
Estimated Primary Completion Date May 2022   (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 and treatment of HF (regardless of left ventricular ejection fraction (LVEF)) for ≥ 3 months and NYHA Class III HF at time of Screening
  4. Subjects should be on stable, optimally titrated medical therapy for at least 30 days, as recommended according to current American Heart Association (AHA)/American College of Cardiology (ACC) guidelines as standard-of-care for HF therapy in the United States, with any intolerance documented.
  5. HF related hospitalization, HF treatment in a hospital day-care setting, or urgent outpatient clinic HF visit for IV diuretics within 12 month (last hospitalization should be 30 days before Screening /Enrollment) and/or N-terminal pro B-type Natriuretic Peptide (NT-proBNP) at time of Screening/ Enrollment defined as:

    1. Subjects with LVEF ≤ 50%: NT-proBNP ≥ 1500 pg/mL.
    2. Subjects with LVEF > 50%: NT-proBNP ≥ 800 pg/mL .

    Thresholds for NT-proBNP (for both LVEF ≤ 50% and LVEF > 50%) will be corrected for body mass index (BMI) using a 4% reduction per BMI unit over 25 kg/m2

  6. Subjects should be on diuretic therapy
  7. Subjects who are physically able to hold the myCordella™ Patient Reader unit (approximate weight 1.3lb) 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
  8. 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
  9. Subject has sufficient Cellular and/ or Wi- Fi Internet coverage at home
  10. 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. Intolerance to all neuro-hormonal antagonists (i.e., intolerance to angiotensin converting enzyme-inhibitors (ACE-I), angiotensin receptor blockers (ARB), angiotensin-neprilysin inhibitors (ARNI), and beta-blockers) due to hypotension or renal dysfunction
  2. ACC/AHA Stage D refractory HF (including having received or currently receiving pharmacologic circulatory support with inotropes)
  3. Subjects with history of recurrent (> 2) pulmonary embolism or deep vein thrombosis
  4. Subjects who have had a major cardiovascular (CV) event (e.g., myocardial infarction, stroke) within 3 months of the Screening Visit
  5. Unrepaired severe valvular disease
  6. Subjects with congenital heart disease or mechanical/tissue right heart valve(s)
  7. Subjects with known coagulation disorders
  8. 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
  9. Known history of life threatening allergy to contrast dye
  10. Subjects whereby RHC is contraindicated
  11. Subjects with an active infection at the Cordella PA Sensor Implant Visit
  12. Subjects with a Glomerular Filtration Rate (GFR) <25 ml/min or who are on chronic renal dialysis
  13. Implanted with Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or CRT-Defibrillator (CRT-D) for less than 90 days prior to screening visit
  14. Received or are likely to receive an advanced therapy (e.g., mechanical circulatory support or lung or heart transplant) in the next 12 months
  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
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: Christine Delano +1 630 473 3200 ext 209 christine.delano@endotronix.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04089059
Other Study ID Numbers  ICMJE ETX-HFS-PA-03
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: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
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 May 2020

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