Recruiting

Observational Study

Sponsor:

Cardioflow Technologies, LLC

Code:

NCT04338503

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Partial IVC occlusion

Study Details

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.

Conditions

Heart Failure

Study ID

NCT04338503

Start date

Sep 1, 2021

Status verified date

Mar, 2023

Completion date

Jun 30, 2024

Anticipated

Primary completion date

Jun 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Interventions and Outcome Measures

Arms

HF patients

Decompensated heart failure patients undergoing right heart catheterization.

Interventions

Partial IVC occlusion

Partial balloon occlusion of the inferior vena cava.

Primary outcome measure

  • Change in pulmonary arterial pressures [ Time Frame: During partial balloon occlusion ]

Central Contacts and Locations

Central contacts

Daniel W Kaiser, MD

6154152586dan@cardioflowtech.com

Locations

Saint Thomas Heart

Recruiting

Nashville, Tennessee, United States, 37205

Contacts

Lynn Peterson

615-222-4504speterso@ascension.org

More Information

Sponsor

Cardioflow Technologies, LLC

Last update posted

Mar 30, 2023

Last verified

Mar, 2023

Keywords

  • pulmonary edema, preload

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cardioflow Technologies, LLC on 2023-03-30.