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

Study Type/Phase: Observational
Status: Not Recruiting

This research study will enroll patients suffering from hearth failure who range from mild symptoms (e.g. shortness of breath when walking, climbing stairs, etc.) to marked limitation during less-than-ordinary activity. This study looks at the relationship between pressures inside the heart and the amount of blood the heart pumps, especially during exercise. The goal of this study is to collect information that will advance our understanding of the causes of shortness of breath and may help create new treatments for the symptoms of heart failure.

This research study includes regularly performed cardiac tests to evaluate heart function, including a cardiopulmonary exercise test (CPET) and a right heart catheterization (small plastic tubes placed inside of the heart, used to measure internal heart pressures and volume of blood pumped). In addition to these regularly performed heart tests, this research study has additional steps to evaluate heart function. This aspect of the study is less likely to affect medical therapy and will be performed primarily for research purposes. During this aspect of the study, a catheter with a small inflatable balloon attached at the end in the deflated position will be placed within a large vessel leading to the heart. This balloon will then be inflated while the patient exercises to prevent the heart from becoming pressure overloaded, which is common in patients with heart failure. The theory being tested in this study is whether preventing the heart from developing high pressures will result in improved symptoms during exercise.

Up to 20 people may be enrolled into this research study. The enrollment will occur in the United States only, specifically at El Camino Hospital.

Speak with your doctor to determine whether you meet the following criteria for participation in this study.

Inclusion Criteria Exclusion Criteria
  • Subjects scheduled to undergo an exercise right heart catheterization at El Camino Hospital.
  • New York Heart Association (NYHA) II or III.
  • Subjects must be between 18 and 80 years of age.
  • A left ventricular ejection fraction ≥ 45%.
  • Subjective or objective evidence (e.g. 6 minute walk test) of impaired exercise capacity.
  • Inability to peddle exercise while laying flat.
  • More than mild valve disease.
  • Subjects without sinus rhythm.
  • Clinical or objective evidence of inducible myocardial ischemia.
  • Significant lung disease, such as prior diagnosis of COPD.
  • Resting or dynamic outflow tract gradient.
  • Severe pulmonary HTN (>60mmHg at rest)
  • Moderate to severe RV dysfunction
  • History of DVT, PE
  • Pregnancy (women of child-bearing age, regardless of contraceptive measures, must be willing to take a pregnancy test prior to the study).
  • Recent major surgery or hospitalization (within 30 days)
  • Participation in another clinical study (within 30 days)
  • Presence of a pacemaker
  • Advanced neurological disease (e.g. dementia)

Principal Investigator

Daniel Kaiser, MD

Sponsor

CardioFlow Technologies, LLC

NCT Number

NCT02984631

Contact

Janet Lamm, Clinical Research Coordinator
Taft Center for Clinical Research
650-962-4566
Janet_Lamm@elcaminohealth.org

For more information about this clinical trial, including trial status, eligibility and full trial listing, visit www.clinicaltrials.gov.

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