PRODIGY Registry in NYHA Class III Heart Failure Patients

Stopped early

Conditions studied: Heart Failure NYHA Class III

In brief

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 .

Key facts

Study ID

NCT03623165

Run by

Endotronix, Inc.

People needed

7

Starts

2018-08-01

Expected to finish

2019-08-15

Last updated by the study team

2019-08-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 Cordella™ Heart Failure System audio/visual cues and operate the Cordella™ 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

You may not qualify if…

• 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

Where it is running

• USC Keck School of Medicine — Los Angeles, California, United States
• UCSF Medical Center — San Francisco, California, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Craig Cardiovascular Center — Gonzales, Texas, United States

Full record on ClinicalTrials.gov

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