NCT06779552 CardioMEMS HF System Coverage With Evidence Development Study
| NCT ID | NCT06779552 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Abbott Medical Devices |
| Condition | Heart Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2025-02-07 |
| Primary Completion | 2032-03 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 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)
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