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NCT06378632 · ClinicalTrials.gov registry record
AN International, Observational, Blinded Study TO Assess THE Performance OF THE Cordio Hearo System
A clinical trial of Heart Failure, sponsored by Cordio Medical.
- Recruiting
- Registry status
- 500
- Enrollment target
- 20
- Study locations
NCT06378632: Recruiting study of Heart Failure, sponsored by Cordio Medical.
NCT06378632 is a study of Heart Failure that is actively recruiting participants, run by Cordio Medical. The registered enrollment target is 500 participants, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (76% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06378632, a study of Heart Failure, is actively recruiting participants, sponsored by Cordio Medical.
- RECRUITING
- Registry status
- 500 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Until the end of the study, each participant will be assigned to one of the following event outcomes: 1. Having at least one protocol-defined Heart Failure Event (HFE) in the CORE period 2. Having no Heart Failure Event (HFE) during the entire CORE period
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 |
What NCT06378632 shows while recruiting
NCT06378632 is an observational study that tracks outcomes without assigning an intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (76% lower).
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.
NCT06378632 names 20 study sites across 6 states, led by Florida, California, Illinois.
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.
What interventions are being tested in trial NCT06378632?
The interventions under investigation include: Hearo App (DEVICE).
Who is sponsoring clinical trial NCT06378632?
This trial is sponsored by Cordio Medical, which has 2 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Heart Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06378632's enrollment target sits among peer trials
500 101st of 397 higher than 294 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Early Feasibility Study of the NORM™ System in Heart Failure Patients (FUTURE-HFII)
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-
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A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients with Heart Failure Who Are Intolerant or Not Eligible for Treatment with Steroidal Mineralocorticoid Receptor Antagonists
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Circulating Markers That Underlie the Transition From Compensated Hypertrophy to Heart Failure
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-
Integration of Telemedicine and Home-Based Cardiac Rehabilitation: Feasibility, Efficacy, and Adherence
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