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NCT05428384 · ClinicalTrials.gov registry record
Validation of CardioMEMS HF System Cardiac Output Algorithm IDE
A clinical trial, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- 89
- Enrollment target
NCT05428384: Completed study, sponsored by Abbott Medical Devices.
NCT05428384 is a clinical trial that has completed, run by Abbott Medical Devices. The registered enrollment target is 89 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05428384 has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- 89 participants
- Enrollment target
Study Summary
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).
Primary Outcome
The primary outcome of this clinical investigation is to estimate Cardiac Output from CardioMEMS HF System data. The estimated Cardiac Output will be evaluated for agreement between the CardioMEMS HF System-derived Cardiac Output and the Cardiac Output values from cardiac Magnetic Resonance Imaging in patients with the CardioMEMS HF System
Interventions
- DEVICE MRI/ CardioMEMS comparison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2022-08-31 |
| Est. Completion | 2024-01-30 |
What the finished NCT05428384 record still lists
NCT05428384 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 89 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which MRI/ CardioMEMS comparison is the first listed.
NCT05428384 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05428384 about?
NCT05428384 is a clinical study titled "Validation of CardioMEMS HF System Cardiac Output Algorithm IDE". 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 ...
What is the current status of trial NCT05428384?
This trial is currently completed. The enrollment target is 89 participants. The study started on 2022-08-31. Estimated completion is 2024-01-30.
What interventions are being tested in trial NCT05428384?
The interventions under investigation include: MRI/ CardioMEMS comparison (DEVICE).
Who is sponsoring clinical trial NCT05428384?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
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