Heart Failure NYHA Class IIINCT03623165
PRODIGY Registry in NYHA Class III Heart Failure Patients
An observational study of Heart Failure NYHA Class III, run by Endotronix, Inc. at 4 sites in United States.
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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure NYHA Class III
- What is being tested?
- Cordella™ Heart Failure System
- Type of treatment
- Medical device
- How many people
- 7 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Aug 2018to 15 Aug 2019
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Craig Cardiovascular Center
Gonzales, Texas, 78679
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
USC Keck School of Medicine
Los Angeles, California, 90033
UCSF Medical Center
San Francisco, California, 94143
About this study
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)
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 .
Read the 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.
- Conditions
- Heart Failure NYHA Class III
- Being tested
- Cordella™ Heart Failure System
- Keywords
- Heart Failure, NYHA Class III
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cordella™ Heart Failure SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm | Cordella™ Heart Failure System Receives: Device: Cordella™ Heart Failure System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline- 6 month
Secondary outcomes (8)
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.
Measured: 12 months post Enrollment
Frequency of Adverse Events
Frequency and rates of adverse events(AEs) throughout the study
Measured: 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
Measured: 12 months post Enrollment
Device/system-related complications
Incidence of Device/system-related complications
Measured: 12 months post Enrollment
Adherence to regular myCordella™ Peripherals measurements
Compliance in using myCordella™ at minimum 5 out of 7 days
Measured: 12 months post Enrollment
Heart Failure Related Medication Changes
Changes to Heart Failure Related Medication from Baseline through 12 month post Enrollment
Measured: 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.)
Measured: 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
Measured: 12 months post Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start1 Aug 2018
- Primary completion15 Aug 2019
- Study completion15 Aug 2019
Why it stopped: same information will be collected in upcoming IDE trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure NYHA Class IIIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Endotronix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrea Sauerland, Study director, Endotronix, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623165
- Sponsor's protocol ID
- ETX-HFS-CHFS-01
- Status last verified
- May 2019
- First submitted
- 27 Jun 2018
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03623165
- Acronym / sponsor ID
- ETX-HFS-CHFS-01
- Conditions
- Heart Failure NYHA Class III
- Keywords
- Heart Failure, NYHA Class III
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: same information will be collected in upcoming IDE trial
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Endotronix, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 15 Aug 2019 (actual)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm | – | Device: Cordella™ Heart Failure SystemCordella™ Heart Failure System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cordella™ Heart Failure SystemThe 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. | Device | Arm |
Primary outcome
Kansas City Cardiomyopathy Questionnaire (KCCQ) change from baseline to 6 month
Time frame: Baseline- 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
8 secondary outcomes
Percentage of device success
Time frame: 12 months post Enrollment
Frequency of Adverse Events
Time frame: 12 months post Enrollment
Heart Failure Hospitalizations
Time frame: 12 months post Enrollment
Device/system-related complications
Time frame: 12 months post Enrollment
Adherence to regular myCordella™ Peripherals measurements
Time frame: 12 months post Enrollment
Heart Failure Related Medication Changes
Time frame: 12 months post Enrollment
Health Economic Questionnaire & Cost Effectiveness Analysis
Time frame: 12 months post Enrollment
Kansas City Cardiomyopathy Questionnaire (KCCQ) change from baseline to 12 month
Time frame: 12 months post Enrollment
Results and safety
The study was stopped early (reason given: same information will be collected in upcoming IDE trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Sauerland study director
Endotronix, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure NYHA Class III, run by Endotronix, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: same information will be collected in upcoming IDE trial). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kansas City Cardiomyopathy Questionnaire (KCCQ) change from baseline to 6 month (time frame: Baseline- 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2019.