PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEndotronix, Inc.
About this trial
This is a prospective, multi-center, open label, randomized control clinical trial evaluating the safety and efficacy of the Cordella™ Pulmonary Artery Sensor System in NYHA Class II-III Heart Failure Patients (PROACTIVE-HF-2 Trial).
The study contains of 5 arms:
NYHA II Cohort - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class II HF patients, where patients have daily access to PAP data.
* Treatment Arm (Group 1) * Active Control Arm (Group 2) * Crossover Arm (Group 3)
NYHA III Cohort - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class III HF patients, where patients have daily access to PAP data, including a randomized sub-study to evaluate a clinician-directed patient self-management strategy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject has given written informed consent 2. Male or female, at least 18 years of age 3. Diagnosis and treatment of HF (regardless of LVEF) for ≥ 3 months and NYHA Class II HF (NYHA II Cohort) or NYHA III (NYHA III Cohort) at time of Screening
HFrEF (EF < 50%): Subject has been on stable medications maximized to the subject's tolerance of ACE-I or ARB or ARNI, MRA, beta-blockers, and SGLT2i as determined by the study investigator for at least 30 days prior to Screening/Enrollment
HFpEF (EF ≥ 50%): Subject has been on stable medication maximized to the subject's tolerance of SGLT2i as determined by the study investigator for at least 30 days prior to Screening/Enrollment 5. NYHA II Cohort- HF related hospitalization within 6 months (last hospitalization should be 30 days before Screening /Enrollment) 5. NYHA III Cohort -HF related hospitalization within 12 month (last hospitalization should be 30 days before Screening/Enrollment)
Disqualifiers
ACC/AHA Stage D refractory HF (including a known history of >24 hours of IV inotropic therapy to support circulation within the past 6 months (other than relation to a procedure))
Subjects with history of recurrent pulmonary embolism (≥2 episodes within 5 years prior to Screening Visit) and/or deep vein thrombosis in the femoral or IJ vein used for access (< 3 month prior to Screening Visit)
Subjects with a resting systolic blood pressure <90 mmHg and/ or severe pre-capillary pulmonary hypertension with a pulmonary artery systolic pressure of ≥70 mm/Hg with pulmonary capillary wedge pressure ≤ 15 mmHg at the Cordella PA Sensor Implant RHC (V2)
Subjects who have had a major cardiovascular (CV) event (e.g., myocardial infarction, stroke) within 3 months of the Screening Visit
Trial design
Design model
Parallel
Treatments tested in this trial
Cordella™ Pulmonary Artery Sensor System
DeviceThe 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, with the goal of reducing heart failure hospitalizations. The system 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. Cordella Sensor Cordella Delivery System myCordella Patient Reader Reader Dock Cordella Calibration Equipment (CalEQ) myCordella Tablet Cordella Data Analysis Platform (CDAP)
Treatment groups
1,750 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: NYHA II Treatment ArmExperimental treatment 1 intervention
Group B: NYHA II Active Control ArmExperimental treatment 1 intervention
Group C: NYHA II Crossover ArmExperimental treatment 1 intervention
Group D: NYHA III Phase I Treatment ArmExperimental treatment 1 intervention
Group E: NYHA III Phase I Active Control ArmExperimental treatment 1 intervention
Group F: NYHA III Clinician-Directed Patient Self-Management Arm (randomized)Experimental treatment 1 intervention
Group G: NYHA III Clinician Management Arm (randomized)Experimental treatment 1 intervention
Group H: NYHA III Clinician Management Arm (Not randomized)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Efficacy- NYHA II Cohort - A composite of first HF event or death from Cardiovascular Death up to 24 months.
A composite endpoint of first HF event or death from CVD up to 24 months.
Time frame
24 months2
Efficacy- NYHA III Cohort (Phase I) - a composite of HF events or death from cardiovascular disease at 6 months
A composite of HF events or death from cardiovascular disease at 6 months
Time frame
12 months3
Safety- Randomized Arm- Freedom from device/system related complication
Freedom from device/system related complication at 24 months
Time frame
24 months4
Safety- Randomized Arm-Freedom from pressure sensor failure
Freedom from pressure sensor failure at 24 months
Time frame
24 monthsSecondary outcomes
1
Efficacy - NYHA II Cohort & NYHA III Cohort - HF Hospitalizations
-Incidence of HFH at 12, 18, and 24 months
Time frame
12 months, 18 months and 24 months2
Efficacy - NYHA II Cohort & NYHA III Cohort- HF Hospitalizations
-Number of HFH at 12- and 24-months post-implant compared to the number of HFH in the 12 and 24 months prior to implant
Time frame
12 months and 24 months3
Efficacy - NYHA II Cohort & NYHA III Cohort - HF Hospitalizations
Combined outcome of : 1. First and recurrent HF Hospitalizations 2. Urgent HF Visits 3. all-cause mortality
Time frame
12 month4
Efficacy - NYHA II Cohort & NYHA III Cohort - HF Hospitalizations
Length of stay
Time frame
Duration of study (to 5 years)Other outcomes
1
Safety - NYHA III Cohort Phase II only: Incidence of serious adverse events at 12 months post Phase II randomization
Incidence of serious adverse events at 12 months post Phase II randomization
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov