NCT06378632 AN INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY TO ASSESS THE PERFORMANCE OF THE CORDIO HEARO SYSTEM
| NCT ID | NCT06378632 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cordio Medical |
| Condition | Heart Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2022-02-11 |
| Primary Completion | 2025-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2022-02-11 with a primary completion date of 2025-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Major Inclusion Criteria: 1. Age 22 or greater 2. Diagnosed with Symptomatic Chronic Heart Failure \[NYHA II-IVa (ambulatory)\] 3. At least one of the following: 1. One ADHF hospitalization in the last 12 months 2. One unplanned IV/SC diuretic administration in the last 6 months 3. Two unplanned IV/SC diuretic administrations in the last 12 months 4. NTProBNP \>500 pg/ml 4. Clinically stable HF according to investigator discretion 5. Willing to participate as evidenced by signing the written informed consent. Major Exclusion Criteria: 1. Unable to comply with daily use of the App, 2. Has had a major cardiovascular event within 3 months prior to enrolment. 3. Had a Cardiac Resynchronization Therapy Device (CRT) implanted or upgrading ≤ 1 month prior to screening visit. 4. Has estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min/1.73. 5. Is likely to undergo heart transplantation/ LVAD within 6 months of Screening Visit. 6. Was treated for a significant COPD
Contact & Investigator
Ronit Haviv, PhD
STUDY DIRECTOR
Cordio Medical
Frequently Asked Questions
Who can join the NCT06378632 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06378632 currently recruiting?
Yes, NCT06378632 is actively recruiting participants. Contact the research team at billt@ihcresearch.com for enrollment information.
Where is the NCT06378632 trial being conducted?
This trial is being conducted at Fairhope, United States, La Jolla, United States, Loma Linda, United States, San Diego, United States and 11 additional locations.
Who is sponsoring the NCT06378632 clinical trial?
NCT06378632 is sponsored by Cordio Medical. The principal investigator is Ronit Haviv, PhD at Cordio Medical. The trial plans to enroll 500 participants.
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