Clinical trial NCT03623165: PRODIGY Registry in NYHA Class III Heart Failure 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)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Failure NYHA Class III
Keywords: Heart Failure
NYHA Class III
Lead sponsor: Endotronix, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-09
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects in this study will be male or female Complex Chronic Care Management (CCM) eligible patients with a diagnosis of NYHA Class III heart failure. Subjects must be diagnosed with heart failure for a minimum of 3 months at time of screening.

Brief 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 .

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ) change from baseline to 6 month
timeFrame: Baseline- 6 month
Secondary outcomes:
measure: Percentage of device success
timeFrame: 12 months post Enrollment
measure: Frequency of Adverse Events
timeFrame: 12 months post Enrollment
measure: Heart Failure Hospitalizations
timeFrame: 12 months post Enrollment
measure: Device/system-related complications
timeFrame: 12 months post Enrollment
measure: Adherence to regular myCordella™ Peripherals measurements
timeFrame: 12 months post Enrollment
measure: Heart Failure Related Medication Changes
timeFrame: 12 months post Enrollment
measure: Health Economic Questionnaire & Cost Effectiveness Analysis
timeFrame: 12 months post Enrollment
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ) change from baseline to 12 month
timeFrame: 12 months post Enrollment
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Keck School of Medicine
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center
state: California
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Gonzales
country: United States
facility: Craig Cardiovascular Center
state: Texas
Study officials:
affiliation: Endotronix, Inc.
name: Andrea Sauerland
role: STUDY_DIRECTOR
References: