Heart Failure Clinical Trial

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Mechanically Optimizing Cardiac Preload in Heart Failure Patients

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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.

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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

Study is for people with:

Heart Failure

Estimated Enrollment:

10

Study ID:

NCT04338503

Recruitment Status:

Recruiting

Sponsor:

Cardioflow Technologies, LLC

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There is 1 Location for this study

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Saint Thomas Heart
Nashville Tennessee, 37205, United States More Info
Lynn Peterson
Contact
615-222-4504
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

10

Study ID:

NCT04338503

Recruitment Status:

Recruiting

Sponsor:


Cardioflow Technologies, LLC

How clear is this clinincal trial information?

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