HF2 Registry - Hemodynamic Frontiers in Heart Failure Registry
Recruiting · NCT06425848 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Kansas Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
Observational
What this trial is 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.
Who can take part
Age range
18 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
12 locations listed across 10 US states.
- 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