PRODIGY Registry in NYHA Class III Heart Failure Patients
NCT ID: NCT03623165
Last Updated: 2019-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
7 participants
OBSERVATIONAL
2018-08-01
2019-08-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
PROACTIVE-HF IDE Trial Heart Failure NYHA Class III
NCT04089059
Real World Effectiveness of the Cordella Pulmonary Artery Sensor System in Patients With Chronic Heart Heart Failure
NCT06783335
PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III
NCT05934487
SIRONA Trial Heart Failure NYHA Class III
NCT03375710
CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients
NCT00531661
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm
Cordella™ Heart Failure System
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Endotronix, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Andrea Sauerland
Role: STUDY_DIRECTOR
Endotronix, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
USC Keck School of Medicine
Los Angeles, California, United States
UCSF Medical Center
San Francisco, California, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Craig Cardiovascular Center
Gonzales, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ETX-HFS-CHFS-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.