RecruitingNCT06779552

CardioMEMS HF System Coverage With Evidence Development Study

Sponsor

Abbott Medical Devices

Enrollment

1,000 participants

Start Date

Feb 7, 2025

Study Type

OBSERVATIONAL

Conditions

Heart Failure

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting real-world evidence on how a small implanted sensor called the CardioMEMS device affects outcomes in patients with heart failure. The device monitors blood pressure in the lungs from inside the body and sends data to doctors remotely, helping them adjust medications before a patient needs to be hospitalized. **You may be eligible if...** - You are 18 years of age or older - You have had the CardioMEMS pressure sensor implanted (for the treatment group) - You have a history of hospitalization for heart failure or high levels of BNP or NT-proBNP (markers of heart strain) **You may NOT be eligible if...** - You have had a heart transplant or a mechanical heart pump implanted - You were hospitalized in cardiogenic shock or with severe infection (sepsis) - You previously had another pulmonary artery pressure sensor implanted (for the control group only) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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