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CardioMEMS HF System Real-World Evidence Post-Approval Study

NCT06306573 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 2500

Last updated 2025-04-03

No results posted yet for this study

Summary

The purpose of this post-approval study (PAS) is to evaluate the long-term safety and effectiveness of the CardioMEMS™ HF System using real-world evidence (RWE) methods.

Conditions

  • Heart Failure NYHA Class II
  • Heart Failure NYHA Class III

Interventions

DEVICE

CardioMEMS HF System

The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data to monitor and manage HF subjects. The CardioMEMS HF System measures PA pressure which clinicians use to initiate or modify HF treatment.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-15
Primary Completion
2027-12-31
Completion
2028-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT06306573 on ClinicalTrials.gov