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PROACTIVE-HF IDE Trial Heart Failure NYHA Class III
NCT04089059 · View on ClinicalTrials.gov ↗
Study Summary
This is a prospective, open- label, single arm, multicenter clinical trial to evaluate the safety and effectiveness of the Cordella PA Sensor System in NYHA Class III Heart Failure Patients compared to a Performance Goal (PG).
Conditions Studied
Interventions
- DEVICE Cordella™ Pulmonary Artery Sensor System
Study Locations (20)
California
- Loma Linda University — Loma Linda
- Eisenhower Medical Center — Rancho Mirage
- UCSD — San Diego
- Kaiser San Francisco — San Francisco
- UCSF Medical Center — San Francisco
- Kaiser Santa Clara — Santa Clara
Florida
- Baptist Health South Florida — Miami
- Ascension Sacred Heart — Pensacola
- USF Health — Tampa
- Cleveland Clinic — Weston
Illinois
- Northwestern — Chicago
- U of Chicago — Chicago
- Heart Centers of Illinois — Palos Park
Alabama
- Ascension St Vincent's — Birmingham
- Huntsville Hospital — Huntsville
Arizona
- Phoenix Cardiovascular Research Group/Insight — Phoenix
Colorado
- South Denver Cardiology — Littleton
Connecticut
- Hartford Hospital — Hartford
Georgia
- Piedmont Athens — Athens
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 738 participants |
| Start Date | 2020-01-10 |
| Est. Completion | 2028-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04089059
The ClinicalTrials.gov registry entry for NCT04089059 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 738 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endotronix, which has 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Heart Failure NYHA Class III appearing as the primary indexed condition, and to 1 intervention — of which Cordella™ Pulmonary Artery Sensor System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04089059 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04089059 about?
NCT04089059 is a clinical study titled "PROACTIVE-HF IDE Trial Heart Failure NYHA Class III". This is a prospective, open- label, single arm, multicenter clinical trial to evaluate the safety and effectiveness of the Cordella PA Sensor System in NYHA Class III Heart Failure Patients compared to a Performance Goal (PG).
What is the current status of trial NCT04089059?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 738 participants. The study started on 2020-01-10. Estimated completion is 2028-04.
What conditions does trial NCT04089059 study?
This clinical trial studies the following conditions: Heart Failure NYHA Class III. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04089059?
The interventions under investigation include: Cordella™ Pulmonary Artery Sensor System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04089059?
This trial is sponsored by Endotronix, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04089059 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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