Mechanically Optimizing Cardiac Preload in Heart Failure Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Diagnostic test: Partial IVC occlusion

• Study Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Decompensated congestive heart failure patients referred for right heart catheterization.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HF patients; Decompensated heart failure patients undergoing right heart catheterization.	Diagnostic test: Partial IVC occlusion; Partial balloon occlusion of the inferior vena cava.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pulmonary arterial pressures	Change in the measured mean pulmonary arterial pressure	During partial balloon occlusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cardiac output	Change in cardiac output measured in liters per minute	During partial balloon occlusion

Collaborators and Investigators

• Sponsor: Cardioflow Technologies, LLC
• Collaborators: Saint Thomas Health

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: April 5, 2020
• First Submitted That Met QC Criteria: April 5, 2020
• First Posted (Actual): April 8, 2020

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: pulmonary edema, preload
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CFT-37215-STH-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No