PRODIGY Registry in NYHA Class III Heart Failure Patients

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 .

Study Overview

• Status: Terminated
• Conditions: Heart Failure NYHA Class III
• Intervention / Treatment: Device: Cordella™ Heart Failure System

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.

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • USC Keck School of Medicine
    • San Francisco, California, United States, 94143
      • UCSF Medical Center
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
  • Texas
    • Gonzales, Texas, United States, 78679
      • Craig Cardiovascular Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Arm; Cordella™ Heart Failure System	Device: Cordella™ Heart Failure System; The Cordella™ Heart Failure System electronically transfers communications and data from a set of medical devices in a heart failure patient's home to a database for storage, retrieval, and display to healthcare providers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kansas City Cardiomyopathy Questionnaire (KCCQ) change from baseline to 6 month	The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. For brevity, only the performance characteristics of the overall summary score are presented in this discussion.The answers patients give to the KCCQ's questions are used to calculate scores in ten scales: Physical Limitation, Symptom Stability, Symptom Frequency, Symptom Burden, Total Symptom, Social Limitation, Self-Efficacy, Quality of Life, Clinical Summary, Overall Summary	Baseline- 6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of device success	Percentage of device success as documented by ability of the System to successfully transmit data (BP, HR, SpO2, weight and optional ECG) to a secure database.	12 months post Enrollment
Frequency of Adverse Events	Frequency and rates of adverse events(AEs) throughout the study	12 months post Enrollment
Heart Failure Hospitalizations	Number of HF hospitalizations, HF treatments in a hospital day-care setting, or urgent outpatient clinic HF visits	12 months post Enrollment
Device/system-related complications	Incidence of Device/system-related complications	12 months post Enrollment
Adherence to regular myCordella™ Peripherals measurements	Compliance in using myCordella™ at minimum 5 out of 7 days	12 months post Enrollment
Heart Failure Related Medication Changes	Changes to Heart Failure Related Medication from Baseline through 12 month post Enrollment	12 months post Enrollment
Health Economic Questionnaire & Cost Effectiveness Analysis	Cost Effectiveness of treating Complex Chronic Care Management (CCM) patients with Heart Failure using the Cordella™ Heart Failure System will be assessed with a questionnaire generated by a Health Economics expert from sponsor. Analyses will include: CCM billing practices, overall economic costs for: hospitalizations (including length of stay), treatment in day-care settings, treatment in urgent care, medication costs, as well as indriect costs (missed days at work, caregiver support, etc.)	12 months post Enrollment
Kansas City Cardiomyopathy Questionnaire (KCCQ) change from baseline to 12 month	The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. For brevity, only the performance characteristics of the overall summary score are presented in this discussion.The answers patients give to the KCCQ's questions are used to calculate scores in ten scales: Physical Limitation, Symptom Stability, Symptom Frequency, Symptom Burden, Total Symptom, Social Limitation, Self-Efficacy, Quality of Life, Clinical Summary, Overall Summary	12 months post Enrollment

Collaborators and Investigators

• Sponsor: Endotronix, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): August 15, 2019
• Study Completion (Actual): August 15, 2019

Study Registration Dates

• First Submitted: June 27, 2018
• First Submitted That Met QC Criteria: August 6, 2018
• First Posted (Actual): August 9, 2018

Study Record Updates

• Last Update Posted (Actual): August 19, 2019
• Last Update Submitted That Met QC Criteria: August 15, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Heart Failure; NYHA Class III
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: ETX-HFS-CHFS-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No