Status:
UNKNOWN
Mechanically Optimizing Cardiac Preload in Heart Failure Patients
Lead Sponsor:
Cardioflow Technologies, LLC
Collaborating Sponsors:
Saint Thomas Health
Conditions:
Heart Failure
Eligibility:
All Genders
18-80 years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04338503
Start Date
September 1 2021
End Date
June 30 2024
Last Update
March 30 2023
Active Locations (1)
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1
Saint Thomas Heart
Nashville, Tennessee, United States, 37205