NCT05428384

Validation of CardioMEMS HF System Cardiac Output Algorithm IDE

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 89 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Heart Failure
• Cardiac Output

Interventions

Type	Name	Description
DEVICE	MRI/ CardioMEMS comparison	Each subject will have CardioMEMS readings paired with MRI scans

Timeline

• Start date: 2022-08-31
• Primary completion: 2024-01-30
• Completion: 2024-01-30
• First posted: 2022-06-23
• Last updated: 2025-05-23

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study