Feasibility Study of the Intravascular Ventricular Assist System (iVAS)
Status: | Recruiting |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/13/2019 |
Start Date: | April 2016 |
End Date: | March 2020 |
Contact: | Lori Rhoten |
Email: | lori.rhoten@nupulsecv.com |
A Clinical Study to Evaluate Ambulatory Counterpulsation for the Treatment of Advanced Heart Failure: A Feasibility Study
The purpose of this feasibility study is to assess the preliminary safety and clinical
performance of the intravascular ventricular assist system (iVAS).
performance of the intravascular ventricular assist system (iVAS).
This is a single-arm, non-randomized study designed to assess the preliminary safety and
clinical performance of the NuPulseCV iVAS.
Data obtained from the study will be used to make device modifications, refine the patient
population, and inform the design a future clinical trial suitable for assessing longer-term
use in heart failure patients.
clinical performance of the NuPulseCV iVAS.
Data obtained from the study will be used to make device modifications, refine the patient
population, and inform the design a future clinical trial suitable for assessing longer-term
use in heart failure patients.
Main Inclusion Criteria:
1. At least 18 years of age.
2. If female, are postmenopausal or surgically sterilized, or have a negative pregnancy
test within seven (7) days of invasive testing.
3. Advanced heart failure (NYHA Class III or IV)
Main Exclusion Criteria:
1. Hypotension treated with the following medications: epinephrine, norepinephrine,
vasopressin, methylene blue, phenylephrine, or angiotensin II.
2. Receiving more than two inotropes.
3. Subclavian stenosis or stent.
4. Currently receiving circulatory support including ECMO, Impella, TandemLife or
equivalents; or any durable VAD.
5. Atrial fibrillation without ventricular pacing.
6. Concomitant, non-cardiac disease process with life expectancy < 1 year.
7. Significant abnormalities of the aorta, such as aneurysms, coarctation of the aorta,
or an extremely tortuous aorta.
8. Severe end-organ dysfunction or failure.
9. Any other condition the heart team believes inappropriate for this study.
We found this trial at
17
sites
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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University of Louisville The University of Louisville is a state supported research university located in...
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New York University More than 175 years ago, Albert Gallatin, the distinguished statesman who served...
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Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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