Validation of CardioMEMS HF System Cardiac Output Algorithm IDE
Public ClinicalTrials.gov record NCT05428384. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The investigation will enroll subjects who have been previously implanted with the CardioMEMS™ Pulmonary Artery Sensor. This clinical investigation is twofold; in the first phase (development phase) data collected will be used to complete development of an algorithm that can estimate cardiac output from CardioMEMS™ Heart Failure (HF) System readings. The second phase (validation phase) of this clinical investigation is intended to compare the Cardiac Output estimate from CardioMEMS HF System to Cardiac Output estimates from Cardiac Magnetic Resonance Imaging (reference standard).
Study identification
- NCT ID
- NCT05428384
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 89 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2022 (Actual)
- Primary completion
- Jan 30, 2024 (Actual)
- Completion
- Jan 30, 2024 (Actual)
- Last update posted
- May 23, 2025
2022 – 2024
United States locations
- U.S. sites
- 8
- U.S. states
- 8
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Piedmont Augusta Hospital | Augusta | Georgia | 30901 | — |
| Kansas University Medical Center | Kansas City | Kansas | 13810 | — |
| Ascension Providence Hospital | Southfield | Michigan | 48075 | — |
| University of Minnesota Medical Center Fairview | Minneapolis | Minnesota | 55455 | — |
| St. Francis Hospital | New York | New York | 25301 | — |
| Sanford USD Medical Center | Sioux Falls | South Dakota | 57105 | — |
| Austin Heart | Austin | Texas | 78756 | — |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05428384, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 23, 2025 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05428384 live on ClinicalTrials.gov.