Hemodynamic Frontiers in Heart Failure Registry

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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).

Locations
United States
California
Scripps Health
RECRUITING
La Jolla
Indiana
Indiana University
RECRUITING
Bloomington
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Minnesota
Fairview Health
NOT_YET_RECRUITING
Maplewood
Minneapolis Heart Institute Foundation/ Allina Health
RECRUITING
Minneapolis
Missouri
Saint Luke's Health System
RECRUITING
Kansas City
North Carolina
University of North Carolina/ Rex Hospital, Inc.
RECRUITING
Raleigh
Oregon
Providence Heart Institute
RECRUITING
Portland
South Carolina
Prisma Health
RECRUITING
Columbia
South Dakota
Sanford Health
RECRUITING
Sioux Falls
Texas
Austin Heart
RECRUITING
Austin
Houston Methodist DeBakey Heart and Vascular Center
RECRUITING
Houston
Contact Information
Primary
Kartik Munshi, MPH
kmunshi@kumc.edu
913-945-6445
Time Frame
Start Date: 2022-10-21
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 2000
Treatments
Retrospective arm
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).
Prospective arm
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.
Related Therapeutic Areas
Sponsors
Leads: University of Kansas Medical Center

This content was sourced from clinicaltrials.gov