Using CardioMEMS to manage heart failure
Official title: CardioMEMS HF System Coverage With Evidence Development Study
Run by Abbott Medical Devices · NCT06779552 · Data updated 2026-11-12
This study tests if using the CardioMEMS system to monitor heart pressure can help people with heart failure stay out of the hospital and live longer compared to standard care.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Abbott Medical Devices Industry-sponsored |
| Locations | 1 site (Pleasanton, California) |
| Status | Recruiting |
| Started | February 7, 2025 |
| Main results expected | March 2032 |
| Study ends | March 2032 |
| Registry record updated | April 3, 2026 |
| Trial ID | NCT06779552 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with a history of acute decompensated heart failure or related congestion who have been implanted with a CardioMEMS pressure sensor.
✕Probably not a fit
Patients who have had a heart transplant, are on durable mechanical circulatory devices, or have been hospitalized with cardiogenic shock or sepsis may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The CardioMEMS CED Study aims to evaluate the effectiveness of the CardioMEMS HF System in managing heart failure by monitoring pulmonary artery pressure. This observational study will compare hospitalization rates and survival outcomes over two years between patients using the CardioMEMS system and those receiving standard care without pressure guidance. The study focuses on real-world applications to determine if this technology can lead to improved long-term health outcomes for heart failure patients.
Why it matters
Potential benefit: If successful, this study could lead to better management strategies for heart failure, potentially reducing hospitalizations and improving survival rates.
How similar studies have gone: Other studies have shown promise in using pulmonary artery pressure monitoring for heart failure management, suggesting that this approach may be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
-
Abbott
Pleasanton, California, United States Recruiting
Study contacts
- Study coordinator: Nessa Johnson
- Email: nessa.johnson@abbott.com
- Phone: 612-283-3865
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.