RecruitingNCT06425848

HF2 Registry - Hemodynamic Frontiers in Heart Failure Registry

Hemodynamic Frontiers in Heart Failure Registry


Sponsor

University of Kansas Medical Center

Enrollment

2,000 participants

Start Date

Oct 21, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria2

  • 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.
  • Patients who meet the expanded FDA indication (BNP elevation without hospitalization or NYHA class II).

Exclusion Criteria3

  • Patients less than 18 years of age.
  • Pregnant women at the scheduled time of PA pressure sensor implant.
  • Patients unable or unwilling to have continuity of care in the heart failure clinic.

Interventions

DEVICEObservational

We are collecting information for both retrospective and prospective arm to further understand the utility of PA pressure sensors.


Locations(12)

Scripps Health

La Jolla, California, United States

Indiana University

Bloomington, Indiana, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Fairview Health

Maplewood, Minnesota, United States

Minneapolis Heart Institute Foundation/ Allina Health

Minneapolis, Minnesota, United States

Saint Luke's Health System

Kansas City, Missouri, United States

University of North Carolina/ Rex Hospital, Inc.

Raleigh, North Carolina, United States

Providence Heart Institute

Portland, Oregon, United States

Prisma Health

Columbia, South Carolina, United States

Sanford Health

Sioux Falls, South Dakota, United States

Austin Heart

Austin, Texas, United States

Houston Methodist DeBakey Heart and Vascular Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06425848


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