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HF2 Registry - Hemodynamic Frontiers in Heart Failure Registry
The purpose of the HF2 (Hemodynamic Frontiers in Heart Failure) registry is to collect relevant patient-level demographic, clinical, laboratory, and hemodynamic data from patients implanted with pulmonary artery pressure sensor at participating centers to advance scientific knowledge about ambulatory hemodynamics monitoring and HF (Heart Failure) therapies. The data collected will be used for retrospective studies, quality improvement, identifying research cohorts, and member-initiated research.
Conditions:
🦠 Heart Failure
🗓️ Study Start (Actual) 21 October 2022
🗓️ Primary Completion (Estimated) 31 December 2030
✅ Study Completion (Estimated) 31 December 2030
👥 Enrollment (Estimated) 2000
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 La Jolla, California, United States
📍 Bloomington, Indiana, United States
📍 Kansas City, Kansas, United States
📍 Maplewood, Minnesota, United States
📍 Minneapolis, Minnesota, United States
📍 Kansas City, Missouri, United States
📍 Raleigh, North Carolina, United States
📍 Portland, Oregon, United States
📍 Columbia, South Carolina, United States
📍 Sioux Falls, South Dakota, United States
📍 Austin, Texas, United States
📍 Houston, Texas, United States
More locations available...

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. All patients would have been or will be implanted per indications from FDA approval/CHAMPION trial. These would be patients with NYHA (New York Heart Association) Class III heart failure who had a prior hospitalization.
    • 2. Patients who meet the expanded FDA indication (BNP elevation without hospitalization or NYHA class II).

    Exclusion Criteria:

    • 1. Patients less than 18 years of age.
    • 2. Pregnant women at the scheduled time of PA pressure sensor implant.
    • 3. Patients unable or unwilling to have continuity of care in the heart failure clinic.
Ages Eligible for Study: 18 Years to 100 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 29 February 2024
  • First Submitted that Met QC Criteria 21 May 2024
  • First Posted 22 May 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 21 May 2024
  • Last Update Posted 22 May 2024
  • Last Verified May 2024
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