Mechanically Optimizing Cardiac Preload in Heart Failure Patients

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04338503
• Other study ID #: CFT-37215-STH-01
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2023
• Source: Cardioflow Technologies, LLC
• Contact: Daniel W Kaiser, MD
• Phone: 6154152586
• Email: dan[@]cardioflowtech.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
United States	Saint Thomas Heart	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Cardioflow Technologies, LLC	Saint Thomas Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pulmonary arterial pressures	Change in the measured mean pulmonary arterial pressure	During partial balloon occlusion
Secondary	Change in cardiac output	Change in cardiac output measured in liters per minute	During partial balloon occlusion