Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06425848
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-02-29
Brief Title:
HF2 Registry - Hemodynamic Frontiers in Heart Failure Registry
Sponsor:
University of Kansas Medical Center
Organization:
University of Kansas Medical Center
Study Overview
Official Title:
Hemodynamic Frontiers in Heart Failure Registry
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HF2 Registry
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None