The Evaluation and Treatment of Elevated Left-Sided Filling Pressures by Balloon Inflation Within the IVC
Status unconfirmed · Not applicable
Conditions studied: Hypertension, Pulmonary, Heart Failure
In brief
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.
Key facts
- Study ID
- NCT02984631
- Run by
- Cardioflow Technologies, LLC
- People needed
- 20
- Starts
- 2016-12-01
- Expected to finish
- 2019-06-01
- Last updated by the study team
- 2018-04-09
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Pregnancy (women of child-bearing age, regardless of contraceptive measures, must be willing to take a pregnancy test prior to the study).
- Recent major surgery or hospitalization (within 30 days)
- Participation in another clinical study (within 30 days)
- Advanced neurological disease (e.g. dementia)
Where it is running
- El Camino Hospital — Mountain View, California, United States (enrolling)
Full record on ClinicalTrials.gov
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