Mechanically Optimizing Cardiac Preload in Heart Failure Patients

Recruiting

• Conditions: Heart Failure
• Interventions: Diagnostic Test: Partial IVC occlusion

• Registration Number: NCT04338503
• Lead Sponsor: Cardioflow Technologies, LLC

Brief Summary

The purpose of the current study is to determine if partial balloon occlusion of the inferior vena cava can optimize cardiac pre-load and subsequently pulmonary pressures and cardiac output as a novel method to unload pulmonary edema and other symptoms of decompensated congestive heart failure. All products in this study are FDA approved and adhere to the specifications of the intended use.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-05
• Study First Submitted QC: 2020-04-05
• Study First Posted: 2020-04-08
• Study Start: 2021-09-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-30
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Subjects scheduled to undergo a right heart catheterization at Saint Thomas Hospital.
2. New York Heart Association (NYHA) II or III.
3. Subjects must be last least 18 years of age.
4. A left ventricular ejection fraction >= 20%.
5. Pulmonary artery occlusion pressure, or pulmonary wedge pressure >20 mmHg.

Exclusion Criteria

1. Subjects without sinus rhythm.
2. Evidence of right heart failure.
3. Patients with primary pulmonary hypertension
4. Pulmonary wedge pressure <15mmHg.
5. Significant lung disease, such as prior diagnosis of COPD.
6. Resting or dynamic outflow tract gradient
7. Patients with left bundle branch block

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HF patients	Partial IVC occlusion	Decompensated heart failure patients undergoing right heart catheterization.

Primary Outcome Measures

Name	Time	Method
Change in pulmonary arterial pressures	During partial balloon occlusion	Change in the measured mean pulmonary arterial pressure

Secondary Outcome Measures

Name	Time	Method
Change in cardiac output	During partial balloon occlusion	Change in cardiac output measured in liters per minute

Trial Locations

Locations (1)

Saint Thomas Heart; 🇺🇸 Nashville, Tennessee, United States