PRODIGY Registry in NYHA Class III Heart Failure Patients

Therapuetic Areas:Cardiology / Vascular Diseases
Age Range:18 - Any
Start Date:August 1, 2018
End Date:December 31, 2019
Contact:Andrea Sauerland
Phone:+1 630- 599-7176

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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)

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 .

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.

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

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
We found this trial at
1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Alan T Kono
Phone: 603-650-8239
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
Lebanon, NH
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Gonzales, Texas 78679
Principal Investigator: William E Craig, MD
Phone: 830-433-4648
Gonzales, TX
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Los Angeles, California 90033
Principal Investigator: Joseph Rahman, MD
Phone: 323-442-7983
Los Angeles, CA
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San Francisco, California 94115
Principal Investigator: Mandar Aras, MD
Phone: 415-476-7600
San Francisco, CA
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