The Evaluation and Treatment of Elevated Left-Sided Filling Pressures by Balloon Inflation Within the IVC

Cardioflow Technologies, LLC20 enrolled

Overview

In patients with heart failure, elevated filling pressures may contribute to symptoms while not improving cardiac output. The current study is focused on evaluating the relationship between exercise capacity, pulmonary pressures, cardiopulmonary parameters, and symptoms of dyspnea in patients with heart failure during exercise.

Previous studies have suggested that intracardiac pressures can be decreased without compromising cardiac function. During an invasive cardiopulmonary exercise test (CPET), catheters are placed within the heart and pulmonary vasculature to evaluate cardiopulmonary function in response to exercise. We will be testing whether pulmonary hypertension can be prevented during exercise by adjusting right ventricular pre-load. We will also be evaluating parameters of cardiopulmonary function during the study.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Hypertension, Pulmonary Heart Failure

Interventions

Preventing pulm HTN during exercisePROCEDURE

Balloon catheter is inflated within the IVC to maintain pulmonary pressures during exercise.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subjects scheduled to undergo an exercise right heart catheterization at El Camino Hospital. 2. New York Heart Association (NYHA) II or III. 3. Subjects must be between 18 and 80 years of age. 4. A left ventricular ejection fraction ≥ 35%. 5. Subjective or objective evidence (e.g. 6 minute walk test) of impaired exercise capacity. 6. Is willing and able to sign an IRB-approved written informed consent Exclusion Criteria: 1. Inability to peddle exercise while laying flat. 2. More than mild valve disease. 3. Clinical or objective evidence of inducible myocardial ischemia. 4. Significant lung disease, such as prior diagnosis of COPD. 5. Resting or dynamic outflow tract gradient. 6. Severe pulmonary HTN (\>60mmHg at rest) 7. Moderate to severe RV dysfunction 8. History of DVT, PE 9. Pregnancy (women of child-bearing age, regardless of contraceptive measures, must be willing to take a pregnancy test prior to the study). 10. Recent major surgery or hospitalization (within 30 days) 11. Participation in another clinical study (within 30 days) 12. Advanced neurological disease (e.g. dementia)

Locations (1)

El Camino Hospital

Mountain View, California, United States

RECRUITING