Trials / Terminated
TerminatedNCT03623165
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)
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 7 (actual)
- Sponsor
- Endotronix, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-08-01
- Primary completion
- 2019-08-15
- Completion
- 2019-08-15
- First posted
- 2018-08-09
- Last updated
- 2019-08-19
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03623165. Inclusion in this directory is not an endorsement.