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PROACTIVE-HF IDE Trial Heart Failure NYHA Class III (PROACTIVE-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04089059
Recruitment Status : Recruiting
First Posted : September 13, 2019
Last Update Posted : March 22, 2022
Sponsor:
Information provided by (Responsible Party):
Endotronix, Inc.

Brief Summary:
This is a prospective, open- label, single arm, multicenter clinical trial to evaluate the safety and effectiveness of the Cordella PA Sensor System in NYHA Class III Heart Failure Patients compared to a Performance Goal (PG).

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 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 NYHA Class III Heart Failure Patients (PROACTIVE- HF Trial)
Actual Study Start Date : January 10, 2020
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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).
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)




Primary Outcome Measures :
  1. Efficacy HF related Hospitalizations (HFH) or all- cause mortality visits [ Time Frame: 6 months ]
    6 month incidence of HF related Hospitalizations (HFH) or all- cause mortality compared to a Performance Goal

  2. Safety: Freedom from device/system related complication [ Time Frame: 6 months ]
    Freedom from device/system related complication at 6 months

  3. Safety: Freedom from pressure sensor failure [ Time Frame: 6 months ]
    Freedom from pressure sensor failure at 6 months


Secondary Outcome Measures :
  1. 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

  2. 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 c. all-cause mortality at 6 months, added together with equal weighting into a total number of events

  3. The number of HF Hospitalizations or Emergency Department/ Hospital Outpatient IV diuretic visit [ Time Frame: 6 months and 12 months ]
    Heart failure hospitalization or Emergency Department / Hospital Outpatient IV diuretic visits at 6 and 12 months

  4. Mortality [ Time Frame: 3 years ]
    Cardiac and all-cause mortality

  5. IV diuretic visits [ Time Frame: 6 months and 12 months ]
    Intravenous (IV) diuretic visits

  6. 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

  7. Pulmonary Artery Pressure (PAP) I [ Time Frame: 6 and 12 months ]
    Change in PAP: a. From Baseline through 6 and 12 months in subjects with a baseline mPAP i. above target range ii. within or below target range iii. Overall

  8. Pulmonary Artery Pressure (PAP) II [ Time Frame: 3 years ]
    Change in Pulmonary Artery Pressure (PAP) before and after 6-Minute Walk Test

  9. 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

  10. Device success [ Time Frame: 3 years ]
    Percentage of device success as documented by ability of the System to successfully transmit PAP data transmit PAP data to a secure database

  11. 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.

  12. 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

  13. 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

  14. Pressure sensor failure [ Time Frame: 3 years ]
    Pressure sensor failure rate throughout the study

  15. Serious adverse events [ Time Frame: 3 years ]
    Frequency of serious adverse events throughout the study

  16. Incidence of HF Hospitalizations or all-cause mortality [ Time Frame: 12 months ]
    Incidence of HF Hospitalizations or all-cause mortality at 12 months

  17. N-terminal pro B-type Natriuretic Peptide (NT-proBNP [ Time Frame: 6 and 12 months ]
    Change of N-terminal pro B-type Natriuretic Peptide (NT-proBNP) from Baseline through 6 and 12 months

  18. Days Alive and Out of Hospital (DAOH) [ Time Frame: 3 years ]
    Days Alive and Out of Hospital (DAOH)

  19. Heart failure related Medication changes [ Time Frame: 3 years ]
    Heart failure related Medication changes



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 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 pulmonary embolism ( ≥2 episodes within 5 years prior to Screening Visit) and/or deep vein thrombosis (< 3 month prior to Screening Visit)

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 with an active treatment arm 20. Subject who is in custody by order of an authority or a court of law


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04089059


Contacts
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Contact: Christine Taveras (630) 216-8531 ext 209 christine.taveras@endotronix.com

Locations
Show Show 55 study locations
Sponsors and Collaborators
Endotronix, Inc.
Investigators
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Study Director: Andrea Sauerland Endotronix, Inc.
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Responsible Party: Endotronix, Inc.
ClinicalTrials.gov Identifier: NCT04089059    
Other Study ID Numbers: ETX-HFS-PA-03
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: March 22, 2022
Last Verified: January 2022

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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
Keywords provided by Endotronix, Inc.:
Heart Failure
Heart Disease
Cardiovascular Disease
Pulmonary Artery Pressure
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases