Mechanically Optimizing Cardiac Preload in Heart Failure Patients

Status unconfirmed

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT04338503

Run by

Cardioflow Technologies, LLC

People needed

10

Starts

2021-09-01

Expected to finish

2024-06-30

Last updated by the study team

2023-03-30

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Saint Thomas Heart — Nashville, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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