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NCT06425848Recruiting

HF2 Registry - Hemodynamic Frontiers in Heart Failure Registry

University of Kansas Medical Center

Start Date

10/21/2022

Completion Date

12/31/2030

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.

Detailed Description

Longitudinal, multi-center, and non-interventional registry. Patients will be identified as eligible for pulmonary artery pressure sensor implant by a heart failure cardiologist from the heart failure clinic. They will consent for device implant and procedure (right heart catheterization) per standard of care. Patients may also consent to the registry participation, which is optional. They will be informed that the registry intends to gather data and that they may be approached in the future for additional research based on their data and clinical situation. Additionally, patients who underwent pulmonary artery pressure sensor implantation from January 1, 2019, will be identified and consent will be obtained for registry participation, which is optional.

Eligibility Criteria

Age Range: 18 years to 100 years

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.

Interventions

DEVICE

Observational

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Conditions

Heart Failure

Locations

Scripps Health

La Jolla, California 92037

United States

Indiana University

Bloomington, Indiana 47401

United States

University of Kansas Medical Center

Kansas City, Kansas 66160

United States

Fairview Health

Maplewood, Minnesota 55109

United States

Minneapolis Heart Institute Foundation/ Allina Health

Minneapolis, Minnesota 55407

United States

Saint Luke's Health System

Kansas City, Missouri 64131

United States

University of North Carolina/ Rex Hospital, Inc.

Raleigh, North Carolina 27607

United States

Providence Heart Institute

Portland, Oregon 97225

United States

Prisma Health

Columbia, South Carolina 29203

United States

Sanford Health

Sioux Falls, South Dakota 57104

United States

Austin Heart

Austin, Texas 78756

United States

Houston Methodist DeBakey Heart and Vascular Center

Houston, Texas 77030

United States