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Recruiting Observational

CardioMEMS HF System Coverage With Evidence Development Study

NCT06779552 · tracked via the Priya Life Science USA tracker
Phase
Observational
Started
2025-02-07
Last updated
2026-04-03

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

CardioMEMS HF System

CardioMEMS HF System: PA Pressure Sensor

Study summary

The purpose of the CardioMEMS CED Study is to determine if pulmonary artery (PA) pressure-guided heart failure management using the CardioMEMS™ HF System improves long-term health outcomes in heart failure (HF) patients in the real-world setting.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Subject implanted with a CardioMEMS pressure sensor (treatment arm only) 2. Subject \>=18 years of age at time of implant 3. Subject has a history of acute decompensated HF or HF-related congestion defined by at least one of the following qualifying event types: HF hospitalization, elevated BNP/NT-proBNP Exclusion Criteria: 1. Subject has history of heart transplant or durable mechanical circulatory device 2. Subject hospitalized with cardiogenic shock or sepsis 3. Subject received prior PA pressure sensor implant (control arm only)

Primary outcome measure(s)

  • HF Hospitalization Rate. — 2 years
    Compare HF hospitalization rate between the treatment and control groups.

Trial sites (1)

FacilityCityRegionStatus
Abbott Pleasanton California Recruiting

More Abbott Medical Devices trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06779552 on ClinicalTrials.gov ↗ ← All trials in the USA