RECRUITING

Mechanically Optimizing Cardiac Preload in Heart Failure Patients

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-09-01
Study Completion:2024-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04338503

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subjects scheduled to undergo a right heart catheterization at Saint Thomas Hospital.
  2. 2. New York Heart Association (NYHA) II or III.
  3. 3. Subjects must be last least 18 years of age.
  4. 4. A left ventricular ejection fraction \>= 20%.
  5. 5. Pulmonary artery occlusion pressure, or pulmonary wedge pressure \>20 mmHg.
  1. 1. Subjects without sinus rhythm.
  2. 2. Evidence of right heart failure.
  3. 3. Patients with primary pulmonary hypertension
  4. 4. Pulmonary wedge pressure \<15mmHg.
  5. 5. Significant lung disease, such as prior diagnosis of COPD.
  6. 6. Resting or dynamic outflow tract gradient
  7. 7. Patients with left bundle branch block

Contacts and Locations

Study Contact

Daniel W Kaiser, MD
CONTACT
6154152586
dan@cardioflowtech.com

Study Locations (Sites)

Saint Thomas Heart
Nashville, Tennessee, 37205
United States

Collaborators and Investigators

Sponsor: Cardioflow Technologies, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-01
Study Completion Date2024-06-30

Study Record Updates

Study Start Date2021-09-01
Study Completion Date2024-06-30

Terms related to this study

Keywords Provided by Researchers

  • pulmonary edema, preload

Additional Relevant MeSH Terms

  • Heart Failure