Heart Failure Clinical Trial
PRODIGY Registry in NYHA Class III Heart Failure Patients
Summary
This is an observational, prospective, single arm, multi-center registry to evaluate the Cordellaâ„¢ Heart Failure System (CHFS) in up to 250 NYHA Class III HF patients .
Full Description
The subjects in this registry will participate in the Screening Visit, and Follow-Up Visits. After the Screening Visit, eligible subjects will be trained on at-home use of the CHFS to measure BP, HR, SpO2, weight and optional ECG.
They will be instructed to perform daily measurements of the parameters which will all be wirelessly transmitted to a secure website for review using the myCordellaâ„¢ Patient Management Portal (PMP). Clinicians will be able to view Blood Pressure (BP), Heart Rate (HR), peripheral capillary oxygen saturation (SpO2), weight and Electrocardiogram (ECG) (optional) data through the myCordellaâ„¢ PMP.
Subjects will return for follow up visits at 3, 6, and 12 months after enrollment or until study termination.
At Month 6, the primary endpoint will be assessed through evaluation of the subjects Quality of Life using the completed KCCQ Questions.
Assessment of secondary endpoints will be performed throughout the study duration, including evaluation of adverse events, and heart failure-related hospitalizations and medication changes. Additionally, Health Economics will be assessed per subject and per site via a detailed site questionnaire.
Eligibility Criteria
Inclusion Criteria:
Subject has given written informed consent
Male or female complex CCM eligible patients or equivalent and at least 18 years of age
Diagnosis of HF ≥ 3 months and NYHA Class III HF at the time of Screening
Subject fluent in English (written and oral) and with sufficient eyesight, hearing, and mental capacity to respond to the Cordellaâ„¢ Heart Failure System audio/visual cues and operate the Cordellaâ„¢ Heart Failure System
Subject has sufficient Cellular and/ or Wi- Fi Internet coverage at home
Subject agrees:
that the treating Investigator is their solely complex CCM physician
to return to the treating Investigator for all scheduled follow up visits and can return to the hospital for follow up
Exclusion Criteria:
Subjects enrolled in another investigational trial.
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
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There are 4 Locations for this study
Los Angeles California, 90033, United States
San Francisco California, 94143, United States
Lebanon New Hampshire, 03756, United States
Gonzales Texas, 78679, United States
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