CardioMEMS HF System Coverage With Evidence Development Study

Part of paid clinical trials in Pleasanton, California.

Sponsor
Abbott Medical Devices
Study ID
NCT06779552
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CardioMEMS HF System — DEVICE
    PA Pressure Sensor

Study Details

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.

Key Dates

Start date
Feb 7, 2025
Status verified
Mar 2026
Primary completion
Mar 31, 2032
Completion
Mar 31, 2032

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Treatment Group
    Heart failure patients implanted with the CardioMEMS PA pressure sensor.
  • Arm: Control Group
    Heart failure patients being managed without PA pressure-monitoring.

Primary Outcome Measure

HF Hospitalization Rate. [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
AbbottPleasantonCalifornia94588
Nessa Johnson
612-283-3865

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