NCT04964817

HFpEF and Symptomatic Obstructive Iliofemoral Venous Disease Study

Heart Failure With Preserved Ejection Fraction (HFpEF) and Symptomatic Obstructive Iliofemoral Venous Disease and Venous Stenting: A Pilot Cohort Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 3 (actual)
• Sponsor: Prairie Education and Research Cooperative · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Heart Failure With Preserved Ejection Fraction
• Venous Disease

Timeline

• Start date: 2021-08-03
• Primary completion: 2023-04-12
• Completion: 2023-04-12
• First posted: 2021-07-16
• Last updated: 2023-04-18

Locations

1 site across 1 country: United States