Trial record 1 of 2 for:
proactive-hf
PROACTIVE-HF IDE Trial Heart Failure NYHA Class III (PROACTIVE-HF)
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| ClinicalTrials.gov Identifier: NCT04089059 |
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Recruitment Status :
Active, not recruiting
First Posted : September 13, 2019
Last Update Posted : April 7, 2023
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Sponsor:
Endotronix, Inc.
Information provided by (Responsible Party):
Endotronix, Inc.
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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 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 456 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 : | September 2023 |
| Estimated Study Completion Date : | March 2026 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Heart Failure
| Arm | Intervention/treatment |
|---|---|
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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).
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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.
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Primary Outcome Measures :
- Efficacy 6 month incidence of HF related Hospitalizations (HFH) or all-cause mortality [ Time Frame: 6 months ]6 month incidence of HF related Hospitalizations (HFH) or all- cause mortality compared to a Performance Goal
- Safety: Freedom from device/system related complication [ Time Frame: 6 months ]Freedom from device/system related complication at 6 months
- Safety: Freedom from pressure sensor failure [ Time Frame: 6 months ]Freedom from pressure sensor failure at 6 months
Secondary Outcome Measures :
- 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 or Emergency Department/Hospital Outpatient IV diuretic visits. [ Time Frame: 6 and 12 months ]Comparison of the number of HF Hospitalizations, Emergency Department/ Hospital Outpatient IV diuretic visits of Cohort #1 and Cohort #2 at 6 and 12 months post implant at 6 months, added together with equal weighting into a total number of events
- Mortality [ Time Frame: 3 years ]Cardiac and all-cause mortality
- IV diuretic visits [ Time Frame: 3 years ]Intravenous (IV) diuretic visits
- Pulmonary Artery Pressure (PAP) [ 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 b. Before and after 6-Minute Walk Test
- 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
- 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 ]Functional status improvement, as measured by NYHA and 6-Minute Walk Test
- Serious adverse events [ Time Frame: 3 years ]Frequency of serious adverse events throughout the study
- Incidence of HF Hospitalizations or all-cause mortality [ Time Frame: 12 months ]Incidence of HF Hospitalizations or all-cause mortality at 12 months
- 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
- Days Alive and Out of Hospital (DAOH) [ Time Frame: 3 years ]Days Alive and Out of Hospital (DAOH)
- Heart failure related Medication changes [ Time Frame: 3 years ]Heart failure related Medication changes
- HF Hospitalization or all-cause mortality [ Time Frame: 12 months ]Incidence of HF Hospitalizations or all-cause mortality at 12 months
- HF Hospitalization, Emergency Department/Hospital Outpatient IV diuretic visits, all-cause mortality [ Time Frame: 6 months ]
Combined outcome of:
- First and recurrent Heart Failure Hospitalizations
- Emergency Department / Hospital Outpatient IV diuretic visits all-cause mortality at 6 months, added together with equal weighting into a total number of events.
- HF Hospitalization, Emergency Department/Hospital Outpatient IV diuretic visits [ Time Frame: 6 and 12 months ]HF Hospitalization, Emergency Department/Hospital Outpatient IV diuretic visits at 6 and 12 months
- Implant procedure and procedure related adverse events and serious adverse events [ Time Frame: 3 years ]Frequency of implant procedure and procedure related adverse events and serious adverse events
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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
- Subject has given written informed consent
- Male or female, at least 18 years of age
- Diagnosis and treatment of HF (regardless of left ventricular ejection fraction (LVEF)) for ≥ 3 months and NYHA Class III HF at time of Screening
- 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, or current European Society of Cardiology (ESC) guidelines for HF treatment in Europe, with any intolerance documented.
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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:
- Subjects with LVEF ≤ 50%: NT-proBNP ≥ 1500 pg/mL.
- 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
- Subjects should be on diuretic therapy
- 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
- 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
- Intolerance to all neuro-hormonal antagonists (i.e., intolerance to ACE-I, ARB, ARNI, and beta-blockers) due to hypotension or renal dysfunction
- ACC/AHA Stage D refractory HF (including having received or currently receiving pharmacologic circulatory support with inotropes)
- 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)
- Subjects who have had a major cardiovascular (CV) event (e.g. myocardial infarction, stroke) within 3 months of the Screening Visit
- Unrepaired severe valvular disease
- Subjects with significant congenital heart disease that has not been repaired and would prevent implantation of the Cordella PA sensor 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 whereby RHC is contraindicated
- Subjects with an active infection at the Sensor Implant Visit
- Subjects with a Glomerular Filtration Rate (GFR) <25 ml/min or who are on chronic renal dialysis
- Implanted with Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or CRT-Defibrillator (CRT-D) for less than 90 days prior to screening visit
- 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 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
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
Locations
Show 79 study locations
Sponsors and Collaborators
Endotronix, Inc.
Investigators
| Study Director: | Andrea Sauerland | Endotronix, Inc. |
| 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: | April 7, 2023 |
| Last Verified: | April 2023 |
| 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.:
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Heart Failure Heart Disease Cardiovascular Disease Pulmonary Artery Pressure |
Additional relevant MeSH terms:
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Heart Failure Heart Diseases Cardiovascular Diseases |