Mechanically Optimizing Cardiac Preload in Heart Failure Patients

Cardioflow Technologies

Status: Enrolling

Conditions: Heart Failure

Treatments: Diagnostic Test: Partial IVC occlusion

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04338503

CFT-37215-STH-01

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

10 participants in 1 patient group

HF patients

Description:

Decompensated heart failure patients undergoing right heart catheterization.

Treatment:

Diagnostic Test: Partial IVC occlusion