PRODIGY Registry in NYHA Class III Heart Failure Patients

Heart Failure NYHA Class III Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03623165
• Other study ID #: ETX-HFS-CHFS-01
• Status: Terminated
• Start date: August 1, 2018
• Est. completion date: August 15, 2019

Study information

• Verified date: May 2019
• Source: Endotronix, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: August 15, 2019
• Est. primary completion date: August 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure NYHA Class III

Intervention

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.

Locations

Country	Name	City	State
United States	Craig Cardiovascular Center	Gonzales	Texas
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	USC Keck School of Medicine	Los Angeles	California
United States	UCSF Medical Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Endotronix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Frequency of Adverse Events	Frequency and rates of adverse events(AEs) throughout the study	12 months post Enrollment
Secondary	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
Secondary	Device/system-related complications	Incidence of Device/system-related complications	12 months post Enrollment
Secondary	Adherence to regular myCordella™ Peripherals measurements	Compliance in using myCordella™ at minimum 5 out of 7 days	12 months post Enrollment
Secondary	Heart Failure Related Medication Changes	Changes to Heart Failure Related Medication from Baseline through 12 month post Enrollment	12 months post Enrollment
Secondary	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
Secondary	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