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AN INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY TO ASSESS THE PERFORMANCE OF THE CORDIO HEARO SYSTEM
NCT06378632 · View on ClinicalTrials.gov ↗
Study Summary
Study Design: This is an international, multicenter, observational, non-interventional, prospective, blinded, single-arm, two-period study, to collect patient utterances that will be retrospectively analyzed to determine the sensitivity and UPNR of the HearO system.
Conditions Studied
Interventions
- DEVICE Hearo App
Study Locations (20)
Florida
- Nature Coast Clinical Research — Crystal River
- Jacksonville Center for Clinical Research — Jacksonville
- Amavita Clinical Research — Miami
- Advance Medical Research Services Corp (AMRS) — Miami
- Baptist Health (Miami Cardiac & Vascular Institute) — Miami
- Comprehensive Medical & Research Center — Plantation
- St. Johns Center for Clinical Research — Saint Augustine
- Tampa General Hospital — Tampa
California
- UC San Diego Health — La Jolla
- VA Loma Linda Healthcare System — Loma Linda
- VA San Diego — San Diego
- University of California, San Francisco — San Francisco
- Kaiser Permanente San Francisco — San Francisco
Illinois
- University of Chicago — Chicago
- Advocate Illinois Masonic Medical Center — Chicago
- Advocate Illinois Masonic Health Center — Downers Grove
- Midwest Cardiovascular Center — Naperville
Alabama
- Eastern Shore Research Institute — Fairhope
Georgia
- West Georgia Cardiology — Carrollton
Kansas
- Robert J. Dole VA Medical Center — Wichita
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2022-02-11 |
| Est. Completion | 2025-07-15 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06378632
The ClinicalTrials.gov registry entry for NCT06378632 describes a study currently listed as recruiting. It is categorized as an unspecified phase, 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 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cordio Medical, which has 30 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 appearing as the primary indexed condition, and to 1 intervention — of which Hearo App 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: NCT06378632 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Florida, California, 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 NCT06378632 about?
NCT06378632 is a clinical study titled "AN INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY TO ASSESS THE PERFORMANCE OF THE CORDIO HEARO SYSTEM". Study Design: This is an international, multicenter, observational, non-interventional, prospective, blinded, single-arm, two-period study, to collect patient utterances that will be retrospectively analyzed to determine the sensitivity and UPNR of the HearO system.
What is the current status of trial NCT06378632?
This trial is currently recruiting. The enrollment target is 500 participants. The study started on 2022-02-11. Estimated completion is 2025-07-15.
What conditions does trial NCT06378632 study?
This clinical trial studies the following conditions: Heart Failure. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06378632?
The interventions under investigation include: Hearo App (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06378632?
This trial is sponsored by Cordio Medical, which has 30 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06378632 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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