CardioMEMS HF System Real-World Evidence Post-Approval Study

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Abbott Medical Devices
Study ID
NCT06306573
Status
Enrolling By Invitation

Conditions

  • Heart Failure NYHA Class II
  • Heart Failure NYHA Class III

Eligibility Criteria

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

Interventions

  • CardioMEMS HF System — DEVICE
    The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data to monitor and manage HF subjects. The CardioMEMS HF System measures PA pressure which clinicians use to initiate or modify HF treatment.

Study Details

The purpose of this post-approval study (PAS) is to evaluate the long-term safety and effectiveness of the CardioMEMS™ HF System using real-world evidence (RWE) methods.

Key Dates

Start date
Dec 15, 2022
Status verified
Apr 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
2,500 participants (estimated)

Arms

  • Arm: Primary Cohort
    The Primary Cohort will include NYHA Class II heart failure subjects receiving a CardioMEMS PA Sensor implant in the commercial setting.
  • Arm: Full Cohort
    The Full Cohort will include both NYHA Class II and Class III heart failure subjects receiving a CardioMEMS PA Sensor implant in the commercial setting.

Primary Outcome Measure

Two-Year Survival in the Primary Cohort (NYHA Class II subjects) [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Abbott MedicalAtlantaGeorgia30313-

Find similar trials in Atlanta, GA

By research site
Abbott Medical· Atlanta, GA

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