Using CardioMEMS to manage heart failure
CardioMEMS HF System Coverage With Evidence Development Study
Abbott Medical Devices · NCT06779552
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 |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abbott Medical Devices (industry) |
| Locations | 1 site (Pleasanton, California) |
| Trial ID | NCT06779552 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promise in using pulmonary artery pressure monitoring for heart failure management, suggesting that this approach may be effective.
Eligibility criteria
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 this trial is running
Pleasanton, California
- Abbott — Pleasanton, California, United States (RECRUITING)
Study contacts
- Study coordinator: Nessa Johnson
- Email: nessa.johnson@abbott.com
- Phone: 612-283-3865
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure