Mechanically Optimizing Cardiac Preload in Heart Failure Patients

• Sponsor: Cardioflow Technologies, LLC (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04338503
• Collaborator: Saint Thomas Hospital, Panama (Other)
• Enrollment: 10
• Location: 1
• Anticipated Duration (Months): 12.9
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Diagnostic Test: Partial IVC occlusion

Study Design

• Study Type: Observational
• Anticipated Enrollment: 10 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Mechanically Optimizing Cardiac Preload Using Partial Inferior Vena Cava Occlusion to Reduce Pulmonary Pressures in Heart Failure Patients in Heart Failure Patients
• Anticipated Study Start Date: Jun 1, 2022
• Anticipated Primary Completion Date: Jun 30, 2023
• Anticipated Study Completion Date: Jun 30, 2023

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Change in pulmonary arterial pressures [During partial balloon occlusion]

   Change in the measured mean pulmonary arterial pressure

Secondary Outcome Measures

1. Change in cardiac output [During partial balloon occlusion]

   Change in cardiac output measured in liters per minute

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saint Thomas Heart	Nashville	Tennessee	United States	37205

Sponsors and Collaborators

• Cardioflow Technologies, LLC
• Saint Thomas Hospital, Panama

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cardioflow Technologies, LLC
• ClinicalTrials.gov Identifier: NCT04338503
• Other Study ID Numbers: CFT-37215-STH-01
• First Posted: Apr 8, 2020
• Last Update Posted: May 12, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Cardioflow Technologies, LLC: pulmonary edema, preload
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of May 12, 2022