CardioMEMS HF System Coverage with Evidence Development Study
NCT ID: NCT06779552
Last Updated: 2025-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2025-02-07
2032-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Treatment Group
Heart failure patients implanted with the CardioMEMS PA pressure sensor.
CardioMEMS HF System
PA Pressure Sensor
Control Group
Heart failure patients being managed without PA pressure-monitoring.
No interventions assigned to this group
Interventions
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CardioMEMS HF System
PA Pressure Sensor
Eligibility Criteria
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Inclusion Criteria
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
2. Subject hospitalized with cardiogenic shock or sepsis
3. Subject received prior PA pressure sensor implant (control arm only)
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Locations
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Abbott
Pleasanton, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CL1027482
Identifier Type: -
Identifier Source: org_study_id
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