CardioMEMS HF System Coverage With Evidence Development Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CardioMEMS HF System.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device CardioMEMS HF System
PA Pressure Sensor
Primary outcome measures
- HF Hospitalization Rate. [Time frame: 2 years]
Secondary outcome measures (1)
- Two-Year Survival [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- Subject implanted with a CardioMEMS pressure sensor (treatment arm only)
- Subject >=18 years of age at time of implant
- 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
- Subject has history of heart transplant or durable mechanical circulatory device
- Subject hospitalized with cardiogenic shock or sepsis
- Subject received prior PA pressure sensor implant (control arm only)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Abbott — Pleasanton
Identifiers
NCT: NCT06779552 · CL1027482