UnknownNot Applicable

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

United States20 participantsStarted 2016-12

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subjects scheduled to undergo an exercise right heart catheterization at El Camino Hospital.
✓. New York Heart Association (NYHA) II or III.
✓. Subjects must be between 18 and 80 years of age.
✓. A left ventricular ejection fraction ≥ 35%.
✓. Subjective or objective evidence (e.g. 6 minute walk test) of impaired exercise capacity.
✓. Is willing and able to sign an IRB-approved written informed consent

Exclusion criteria

✕. Inability to peddle exercise while laying flat.
✕. More than mild valve disease.
✕. Clinical or objective evidence of inducible myocardial ischemia.
✕. Significant lung disease, such as prior diagnosis of COPD.
✕. Resting or dynamic outflow tract gradient.
✕. Severe pulmonary HTN (\>60mmHg at rest)
✕. Moderate to severe RV dysfunction
✕. History of DVT, PE

What they're measuring

Reduction in respiratory rate at matched levels of exercise.

Timeframe: During the CPET, within 30 minutes of study.

Trial details

NCT IDNCT02984631

SponsorCardioflow Technologies, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-06

Contact for this trial

Daniel W Kaiser, MD

danielkaisermd@gmail.com

View on ClinicalTrials.gov More Hypertension, Pulmonary trials