HFpEF and Symptomatic Obstructive Iliofemoral Venous Disease Study

NCT ID: NCT04964817

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 3 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-03
• Study Completion Date: 2023-04-12

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Willing and able to provide informed consent and comply with all study requirements
• Age ≥ 40 years of age
• Stable, symptomatic heart failure with preserved ejection fraction and a H2FpEF Score ≥4
• Presence of non-malignant inferior vena cava obstruction, a unilateral or bilateral chronic non-malignant obstruction of the common femoral vein, external iliac vein, common iliac vein, or any combination thereof, defined as a ≥50% reduction in target vessel lumen diameter defined by screening MRV, CTV and confirmed by a 50% reduction in luminal area as assessed by intraprocedural IVUS.
• Previous (>6 months) history of ilio-femoral and/or lower extremity deep venous thrombosis associated with a residual ilio-femoral venous obstruction ≥50% by MRV, CTV.
• Clinically significant venous obstruction meeting CEAP Clinical classification ≥3.
• Negative pregnancy test in females of child-bearing potential

Exclusion Criteria

• Subject hospitalized for acute compensated heart failure within 60 days prior to enrollment
• Presence of history of clinically significant pulmonary emboli within 6 months prior to enrollment.
• Subject has any permanent neurologic defect that may cause non-compliance with the protocol
• Subject has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematous).
• Subject has an allergy to contrast media that cannot be adequately pre-treated prior to the required diagnostic and/or endovascular procedures.
• Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding.
• Subject has renal failure or chronic kidney disease with glomerular filtration rate (GFR) ≤ 30 mL/min or Modification of Diet in Renal Disease (MDRD) study equation result of ≤ 30 mL/min per 1.73 m2.
• Subject has white blood cell (WBC) count < 3.0 (3000 cells/mm3) within 7 days prior to index procedure.
• Subject has a platelet count < 80,000 cells/mm3 or > 700,000 cells/mm3 ≤ 7 days pre procedure; uncorrected hemoglobin of ≤9 g/dL.
• Subject has known or suspected active systemic infection evidenced by WBC > 14.0 (14,000/mm3).
• Subject is currently participating in another investigational drug or device study.
• Subject intends to participate in another investigational drug or device study within 30 days after the index procedure.
• Subject has moderate or severe pulmonary disease (i.e., COPD) considered by Investigator to be a major contributing factor to the subject's exertional dyspnea

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

Medtronic

INDUSTRY

Sponsor Role: collaborator

Philips Healthcare

INDUSTRY

Sponsor Role: collaborator

Prairie Education and Research Cooperative

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Krishna Rocha-Singh, MD

Role: PRINCIPAL_INVESTIGATOR

Prairie Cardiovascular Consultants

Locations

Prairie Heart Institute at St. Johns Hospital

Springfield, Illinois, United States

Countries

United States

Other Identifiers

1309580

Identifier Type: -

Identifier Source: org_study_id