Recruiting

Balloon Inflation

Sponsor:

Cardioflow Technologies, LLC

Code:

NCT02984631

Conditions

Hypertension, Pulmonary

Heart Failure

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Preventing pulm HTN during exercise

Study Details

Brief 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.

Conditions

Hypertension, Pulmonary

Heart Failure

Study ID

NCT02984631

Start date

Dec, 2016

Status verified date

Apr, 2018

Completion date

Jun, 2019

Anticipated

Primary completion date

Jun, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Preventing pulm HTN during exercise 2nd

Standard of care invasive cardiopulmonary exercise test (CPET) followed by CPET with pre-load control.

other: Preventing pulm HTN during exercise 1st

Pre-load control of invasive cardiopulmonary exercise test (CPET) followed by standard CPET.

Interventions

Preventing pulm HTN during exercise

Balloon catheter is inflated within the IVC to maintain pulmonary pressures during exercise.

Primary outcome measure

  • Reduction in respiratory rate at matched levels of exercise. [ Time Frame: During the CPET, within 30 minutes of study. ]

Central Contacts and Locations

Central contacts

Daniel W Kaiser, MD

danielkaisermd@gmail.com

Locations

El Camino Hospital

Recruiting

Mountain View, California, United States, 94040

More Information

Sponsor

Cardioflow Technologies, LLC

Last update posted

Apr 9, 2018

Last verified

Apr, 2018

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 2018-04-09.