Mechanically Optimizing Cardiac Preload in Heart Failure Patients

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.

Full Title of Study: “Mechanically Optimizing Cardiac Preload Using Partial Inferior Vena Cava Occlusion to Reduce Pulmonary Pressures in Heart Failure Patients in Heart Failure Patients”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 30, 2024

Interventions

  • Diagnostic Test: Partial IVC occlusion
    • Partial balloon occlusion of the inferior vena cava.

Arms, Groups and Cohorts

  • HF patients
    • Decompensated heart failure patients undergoing right heart catheterization.

Clinical Trial Outcome Measures

Primary Measures

  • Change in pulmonary arterial pressures
    • Time Frame: During partial balloon occlusion
    • Change in the measured mean pulmonary arterial pressure

Secondary Measures

  • Change in cardiac output
    • Time Frame: During partial balloon occlusion
    • Change in cardiac output measured in liters per minute

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cardioflow Technologies, LLC
  • Collaborator
    • Saint Thomas Health
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Daniel W Kaiser, MD, 6154152586, dan@cardioflowtech.com

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