PRODIGY Registry in NYHA Class III Heart Failure Patients

Endotronix

Status: Terminated

Conditions: Heart Failure NYHA Class III

Treatments: Device: Cordella™ Heart Failure System

Study type: Observational

Funder types: Industry

Identifiers

NCT03623165

ETX-HFS-CHFS-01

Details and patient eligibility

About

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 .

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 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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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:

   1. that the treating Investigator is their solely complex CCM physician
   2. to return to the treating Investigator for all scheduled follow up visits and can return to the hospital for follow up

Exclusion criteria

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

Trial design

7 participants in 1 patient group

Arm

Description:

Cordella™ Heart Failure System

Treatment:

Device: Cordella™ Heart Failure System