NCT06425848

HF2 Registry - Hemodynamic Frontiers in Heart Failure Registry

Hemodynamic Frontiers in Heart Failure Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure

Interventions

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

Timeline

• Start date: 2022-10-21
• Primary completion: 2030-12-31
• Completion: 2030-12-31
• First posted: 2024-05-22
• Last updated: 2024-05-22

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated device study