NCT04338503
Recruiting
Not Applicable
Mechanically Optimizing Cardiac Preload Using Partial Inferior Vena Cava Occlusion to Reduce Pulmonary Pressures in Heart Failure Patients in Heart Failure Patients
ConditionsHeart Failure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Cardioflow Technologies, LLC
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Change in pulmonary arterial pressures
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects scheduled to undergo a right heart catheterization at Saint Thomas Hospital.
- •New York Heart Association (NYHA) II or III.
- •Subjects must be last least 18 years of age.
- •A left ventricular ejection fraction \>= 20%.
- •Pulmonary artery occlusion pressure, or pulmonary wedge pressure \>20 mmHg.
Exclusion Criteria
- •Subjects without sinus rhythm.
- •Evidence of right heart failure.
- •Patients with primary pulmonary hypertension
- •Pulmonary wedge pressure \<15mmHg.
- •Significant lung disease, such as prior diagnosis of COPD.
- •Resting or dynamic outflow tract gradient
- •Patients with left bundle branch block
Outcomes
Primary Outcomes
Change in pulmonary arterial pressures
Time Frame: During partial balloon occlusion
Change in the measured mean pulmonary arterial pressure
Secondary Outcomes
- Change in cardiac output(During partial balloon occlusion)
Study Sites (1)
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