NCT02984631

The Evaluation and Treatment of Elevated Left-Sided Filling Pressures by Balloon Inflation Within the IVC

The Evaluation and Treatment of Elevated Left-Sided Filling Pressures by Balloon Inflation Within the Interior Vena Cava

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Cardioflow Technologies, LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

In patients with heart failure, elevated filling pressures may contribute to symptoms while not improving cardiac output. The current study is focused on evaluating the relationship between exercise capacity, pulmonary pressures, cardiopulmonary parameters, and symptoms of dyspnea in patients with heart failure during exercise.

Detailed description

Previous studies have suggested that intracardiac pressures can be decreased without compromising cardiac function. During an invasive cardiopulmonary exercise test (CPET), catheters are placed within the heart and pulmonary vasculature to evaluate cardiopulmonary function in response to exercise. We will be testing whether pulmonary hypertension can be prevented during exercise by adjusting right ventricular pre-load. We will also be evaluating parameters of cardiopulmonary function during the study.

Conditions

• Hypertension, Pulmonary
• Heart Failure

Interventions

Type	Name	Description
PROCEDURE	Preventing pulm HTN during exercise	Balloon catheter is inflated within the IVC to maintain pulmonary pressures during exercise.

Timeline

• Start date: 2016-12-01
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2016-12-07
• Last updated: 2018-04-09

Locations

1 site across 1 country: United States