PRODIGY Registry in NYHA Class III Heart Failure Patients

NCT03623165 | Terminated

• 1 other identifier: ETX-HFS-CHFS-01
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 4

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 .

Conditions

Heart Failure NYHA Class III

Keywords

Heart Failure; NYHA Class III

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Percentage of device success

  12 months post Enrollment

• Frequency of Adverse Events

  12 months post Enrollment

• Heart Failure Hospitalizations

  12 months post Enrollment

• Device/system-related complications

  12 months post Enrollment

• Adherence to regular myCordella™ Peripherals measurements

  12 months post Enrollment

Study Arms (1)

Arm

Cordella™ Heart Failure System

Device: Cordella™ Heart Failure System

Interventions

Cordella™ Heart Failure System DEVICE

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.

Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• Endotronix, Inc.: lead

Study Sites (4)

USC Keck School of Medicine

Los Angeles, California, 90033, United States

Location

UCSF Medical Center

San Francisco, California, 94143, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Craig Cardiovascular Center

Gonzales, Texas, 78679, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Andrea Sauerland

  Endotronix, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: August 9, 2018
• Study Start: August 1, 2018
• Primary Completion: August 15, 2019
• Study Completion: August 15, 2019
• Last Updated: August 19, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)