Heart Failure
Conditions
Keywords
pulmonary edema, preload
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.
Interventions
DIAGNOSTIC_TESTPartial IVC occlusion
Partial balloon occlusion of the inferior vena cava.
Sponsors
Saint Thomas Health
Cardioflow Technologies, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pulmonary arterial pressures | During partial balloon occlusion | Change in the measured mean pulmonary arterial pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in cardiac output | During partial balloon occlusion | Change in cardiac output measured in liters per minute |
Countries
United States
Contacts
Primary ContactDaniel W Kaiser, MD
Outcome results
None listed