Trials / Recruiting
RecruitingNCT06779552
CardioMEMS HF System Coverage With Evidence Development Study
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,000 (estimated)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
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.
Detailed description
The CardioMEMS CED Study will assess 2-year HF hospitalization rates and survival for all-cause mortality in heart failure subjects managed with the CardioMEMS HF system, as compared to a contemporaneous control of HF subjects managed without PA pressure-guidance.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CardioMEMS HF System | PA Pressure Sensor |
Timeline
- Start date
- 2025-02-07
- Primary completion
- 2032-03-01
- Completion
- 2032-03-01
- First posted
- 2025-01-16
- Last updated
- 2026-04-03
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06779552. Inclusion in this directory is not an endorsement.