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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02984631
• Other study ID #: CFT-37215-ECH-02
• Status: Recruiting
• Phase: N/A
• First received: December 3, 2016
• Last updated: April 5, 2018
• Start date: December 2016
• Est. completion date: June 2019

Study information

• Verified date: April 2018
• Source: Cardioflow Technologies, LLC
• Contact: Daniel W Kaiser, MD
• Email: danielkaisermd[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Subjects scheduled to undergo an exercise right heart catheterization at El Camino Hospital.

2. New York Heart Association (NYHA) II or III.

3. Subjects must be between 18 and 80 years of age.

4. A left ventricular ejection fraction = 35%.

5. Subjective or objective evidence (e.g. 6 minute walk test) of impaired exercise capacity.

6. Is willing and able to sign an IRB-approved written informed consent

Exclusion Criteria:

1. Inability to peddle exercise while laying flat.

2. More than mild valve disease.

3. Clinical or objective evidence of inducible myocardial ischemia.

4. Significant lung disease, such as prior diagnosis of COPD.

5. Resting or dynamic outflow tract gradient.

6. Severe pulmonary HTN (>60mmHg at rest)

7. Moderate to severe RV dysfunction

8. History of DVT, PE

9. Pregnancy (women of child-bearing age, regardless of contraceptive measures, must be willing to take a pregnancy test prior to the study).

10. Recent major surgery or hospitalization (within 30 days)

11. Participation in another clinical study (within 30 days)

12. Advanced neurological disease (e.g. dementia)

Related Conditions & MeSH terms

• Heart Failure
• Hypertension, Pulmonary

Intervention

Procedure:
• Preventing pulm HTN during exercise
Balloon catheter is inflated within the IVC to maintain pulmonary pressures during exercise.

Locations

Country	Name	City	State
United States	El Camino Hospital	Mountain View	California

Sponsors (1)

Lead Sponsor	Collaborator
Cardioflow Technologies, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in respiratory rate at matched levels of exercise.		During the CPET, within 30 minutes of study.
Secondary	Change in patient symptoms-- dyspnea and leg discomfort (Borg units)		During the CPET, within 30 minutes of study.
Secondary	Change in ventilatory threshold		During the CPET, within 30 minutes of study.
Secondary	Change in exercise time		During the CPET, within 30 minutes of study.
Secondary	Change in heart rate for given level of exercise (work rate in watts)		During the CPET, within 30 minutes of study.
Secondary	Change in anaerobic threshold		During the CPET, within 30 minutes of study.
Secondary	Change in pulmonary diastolic pressure for a given level of exercise (work rate)		During the CPET, within 30 minutes of study.
Secondary	Change in dead space ventilation at a given level of exercise (and VE/VCO2 slope)		During the CPET, within 30 minutes of study.
Secondary	Change in cardiac output at a given level of exercise		During the CPET, within 30 minutes of study.
Secondary	Determining predictors of peak VO2		During the CPET, within 30 minutes of study.
Secondary	Change in oxygen uptake at a given level of exercise		During the CPET, within 30 minutes of study.
Secondary	Change in pH level at a given level of exercise		During the CPET, within 30 minutes of study.
Secondary	Change in Peak VO2		During the CPET, within 30 minutes of study.