Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Mandar Aras

Description

Summary

This is an observational, prospective, single arm, multi-center registry to evaluate the Cordella™ Heart Failure System (CHFS) in up to 250 NYHA Class III HF patients .

Official Title

An Observational, Prospective, Single Arm, Multi-Center Registry to Evaluate the Cordella™ Heart Failure System in New York Heart (NYHA) Class III Heart Failure Patients (PRODIGY Registry)

Details

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 myCordella™ 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 myCordella™ 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.

Keywords

Heart Failure NYHA Class III Heart Failure NYHA Class III Cordella™ Heart Failure System

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Subject has given written informed consent
  2. Male or female complex CCM eligible patients or equivalent and at least 18 years of age
  3. Diagnosis of HF ≥ 3 months and NYHA Class III HF at the time of Screening
  4. Subject fluent in English (written and oral) and with sufficient eyesight, hearing,and mental capacity to respond to the Cordella™ Heart Failure System audio/visual cues and operate the Cordella™ Heart Failure System
  5. Subject has sufficient Cellular and/ or Wi- Fi Internet coverage at home
  6. Subject agrees:
  7. that the treating Investigator is their solely complex CCM physician
  8. to return to the treating Investigator for all scheduled follow up visits and can return to the hospital for follow up

You CAN'T join if...

  1. Subjects enrolled in another investigational trial.
  2. 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
  3. Severe illness, other than heart disease, which would limit survival to <1 year

Locations

  • UCSF Medical Center not yet accepting patients
    San Francisco California 94143 United States
  • USC Keck School of Medicine not yet accepting patients
    Los Angeles California 90033 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Endotronix, Inc.
ID
NCT03623165
Lead Scientist
Mandar Aras
Study Type
Observational [Patient Registry]
Last Updated