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Heart Failure With Preserved Ejection Fraction (HFpEF) and Symptomatic Obstructive Iliofemoral Venous Disease and Venous Stenting: A Pilot Cohort Study
To ascertain the potential symptom improvement assessed by Cardiopulmonary Exercise Testing (CPET) in subjects with heart failure with preserved ejection fraction (HFpEF) and nonthrombotic iliofemoral venous lesions and/or iliocaval obstruction defined by MR or CT venography AND CEAP Clinical Category ≥3 prior to venous stenting.
Primary Objective: Evaluate potential improvement in metrics of functional capacity assessed by Cardiopulmonary Exercise Testing performed before and after venous stenting of an ≥50% iliofemoral venous obstruction by MR or CT venography and confirmed by intra-procedural IVUS in a prospective patient cohort presenting with heart failure with preserved ejection fraction with a H2FpEF score of ≥4 AND a CEAP Category ≥3. Secondary Objectives: Identify patient demographic, baseline laboratory, imaging, procedural and Cardiopulmonary Exercise Testing variables and the FDA-approved Minnesota Living with Heart Failure Questionnaire as a Medical Device Development Tool (MDDT) in patients with and without functional improvement as assessed by Cardiopulmonary Exercise Testing VO2max after successful venous stenting of iliofemoral/iliocaval venous obstructions.
Age
40 - No limit years
Sex
ALL
Healthy Volunteers
No
Prairie Heart Institute at St. Johns Hospital
Springfield, Illinois, United States
Start Date
August 3, 2021
Primary Completion Date
April 12, 2023
Completion Date
April 12, 2023
Last Updated
April 18, 2023
3
ACTUAL participants
Lead Sponsor
Prairie Education and Research Cooperative
Collaborators
NCT07057466
NCT07093528
Data Source & Attribution
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