HF2 Registry - Hemodynamic Frontiers in Heart Failure Registry

University of Kansas

Status: Enrolling

Conditions: Heart Failure

Treatments: Device: Observational

Study type: Observational

Funder types: Other

Identifiers

NCT06425848

STUDY00147383

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,000 participants in 2 patient groups

Retrospective arm

Description:

Patients who underwent PA pressure implantation from January 1, 2019 will be identified for registry participation. Patients who were implanted before November 8, 2022 will be considered enrolled in the retrospective arm of the registry and may not need to consent if consent waiver is granted by the institutional IRB (Institutional Review Board).

Treatment:

Device: Observational

Prospective arm

Description:

Patients will be identified as eligible for PA pressure sensor implant by a heart failure cardiologist. Patients will consent for device implant and procedure (right heart catheterization) as per standard of care. Patients may also consent to registry participation as per local institutional guidelines and requirements.

Treatment:

Device: Observational