Minneapolis Heart Institute Foundation | Minneapolis, MN
Status
Conditions
Treatments
About
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:
Randomized Arm - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class II HF patients.
Single Arm - To demonstrate safety and efficacy of the Cordella PA Sensor System linked with a clinician-directed patient self-management strategy in NYHA Class III HF patients.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion 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 LVEF) for ≥ 3 months and NYHA Class II HF (Randomized Arm) or NYHA III (Single Arm) at time of Screening
Subjects should be receiving appropriate medical therapy for heart failure according to current AHA/ACC guidelines as standard-of-care for HF therapy in the United States, or current ESC guidelines for HF treatment in Europe for at least 30 days prior to the Screening/Enrollment visit. Stable is defined as no more than a 100% increase or 50% decrease in dose. These criteria may be waived if a subject is intolerant of ACE-I, ARB, ARNI), MRA, beta-blockers, or SGLT2i, subject is unable to afford these agents, subject has contraindications to these agents, or these agents are not indicated under the Guidelines. Such intolerance, lack of affordability, contraindications, or lack of indications must be documented.
Randomized Arm- HF related hospitalization or urgent HF visit within 6 months (last hospitalization should be 30 days before Screening /Enrollment)
Single Arm-HF related hospitalization or urgent HF visit 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 ≥ 1000 pg/mL.
Subjects with LVEF > 50%: NT-proBNP ≥ 700 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 (≥40 mg] furosemide or equivalent) for ≥ 1 month at time of Screening
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:
Primary purpose
Allocation
Interventional model
Masking
1,650 participants in 5 patient groups
Loading...
Central trial contact
Jami Smith
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal