Mechanically Optimizing Cardiac Preload in Heart Failure Patients

Cardioflow Technologies, LLC10 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Heart Failure

Interventions

Partial IVC occlusionDIAGNOSTIC_TEST

Partial balloon occlusion of the inferior vena cava.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Saint Thomas Heart

Nashville, Tennessee, United States

RECRUITING

Outcomes

Primary Outcomes

Change in pulmonary arterial pressures

Change in the measured mean pulmonary arterial pressure

Time frame: During partial balloon occlusion

Secondary Outcomes

Change in cardiac output

Change in cardiac output measured in liters per minute

Time frame: During partial balloon occlusion

Central Contacts

Daniel W Kaiser, MD

CONTACT

6154152586 dan@cardioflowtech.com

Data from ClinicalTrials.gov

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