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
This trial does not accept healthy volunteersQualifiers
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 population
The study population will include Heart Failure patients in the United States implanted with the CardioMEMS PA pressure sensor and HF patients being managed without PA pressure-monitoring.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
CardioMEMS HF System
DevicePA Pressure Sensor
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: Treatment Group1 intervention
Group B: Control Group0 interventions
Trial outcomes
Primary outcomes
1
HF Hospitalization Rate.
Compare HF hospitalization rate between the treatment and control groups.
Time frame
2 yearsSecondary outcomes
1
Two-Year Survival
Compare survival between the treatment and control groups.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov