Mechanically Optimizing Cardiac Preload in Heart Failure Patients

Description

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.

Conditions

Heart Failure

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Study Overview

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Study Details

Study 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.

Mechanically Optimizing Cardiac Preload Using Partial Inferior Vena Cava Occlusion to Reduce Pulmonary Pressures in Heart Failure Patients in Heart Failure Patients

Mechanically Optimizing Cardiac Preload in Heart Failure Patients

Condition
Heart Failure
Intervention / Treatment

-

Contacts and Locations

Nashville

Saint Thomas Heart, Nashville, Tennessee, United States, 37205

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cardioflow Technologies, LLC,

Study Record Dates

2024-06-30