CardioMEMS HF System Coverage With Evidence Development Study
ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAbbott Medical Devices
About this trial
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
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- CardioMEMS HF System
Treatment groups
1,000 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov