Heart Failure
Conditions
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.
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.
Interventions
DEVICECardioMEMS HF System
PA Pressure Sensor
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HF Hospitalization Rate. | 2 years | Compare HF hospitalization rate between the treatment and control groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Two-Year Survival | 2 years | Compare survival between the treatment and control groups. |
Countries
United States
Contacts
CONTACTNessa Johnson
Outcome results
None listed