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Validation of CardioMEMS HF System Cardiac Output Algorithm IDE

NCT05428384 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 89

Last updated 2025-05-23

No results posted yet for this 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).

Conditions

Interventions

DEVICE

MRI/ CardioMEMS comparison

Each subject will have CardioMEMS readings paired with MRI scans

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2024-01-30
Completion
2024-01-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05428384 on ClinicalTrials.gov