Feasibility Study of the Intravascular Ventricular Assist System (iVAS)
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|ClinicalTrials.gov Identifier: NCT02645539|
Recruitment Status : Unknown
Verified November 2019 by NuPulseCV.
Recruitment status was: Recruiting
First Posted : January 1, 2016
Last Update Posted : November 13, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Heart Failure NYHA Class III Heart Failure NYHA Class IV||Device: intravascular ventricular assist system (iVAS)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Study to Evaluate Ambulatory Counterpulsation for the Treatment of Advanced Heart Failure: A Feasibility Study|
|Actual Study Start Date :||April 2016|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Single Arm
All patients are treated with the intravascular ventricular assist system (iVAS).
Device: intravascular ventricular assist system (iVAS)
A mechanical circulatory support device using the principles of counterpulsation.
- Survival to transplant or stroke-free survival [ Time Frame: 30 days ]
- Number of patients who deteriorate requiring escalation of treatment [ Time Frame: 30 days ]
- Rate of occurrence of all adverse events [ Time Frame: 30 days ]
- Rate of occurrence of procedure-related adverse events [ Time Frame: 30 days ]
- Rate of occurrence of serious device-related adverse events [ Time Frame: 30 days ]
- Number of patients demonstrating improvement in NYHA Classification [ Time Frame: 30 days ]
- Number of patients demonstrating improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) - quality of life (QOL) [ Time Frame: 30 days ]
- Number of patients demonstrating improvement six minute walk test (6MWT) and two minute step test (2MST) [ Time Frame: 30 days ]
- Number of patients demonstrating improvement in Seattle Heart Failure Model Score [ Time Frame: 30 days ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Main Inclusion Criteria:
- At least 18 years of age.
- If female, are postmenopausal or surgically sterilized, or have a negative pregnancy test within seven (7) days of invasive testing.
- Advanced heart failure (NYHA Class III or IV)
Main Exclusion Criteria:
- Hypotension treated with the following medications: epinephrine, norepinephrine, vasopressin, methylene blue, phenylephrine, or angiotensin II.
- Receiving more than two inotropes.
- Subclavian stenosis or stent.
- Currently receiving circulatory support including ECMO, Impella, TandemLife or equivalents; or any durable VAD.
- Atrial fibrillation without ventricular pacing.
- Concomitant, non-cardiac disease process with life expectancy < 1 year.
- Significant abnormalities of the aorta, such as aneurysms, coarctation of the aorta, or an extremely tortuous aorta.
- Severe end-organ dysfunction or failure.
- Any other condition the heart team believes inappropriate for this study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02645539
|Contact: Lori Rhoten||1-800-216-1778||CTT@nupulsecv.com|
|Other Study ID Numbers:||
|First Posted:||January 1, 2016 Key Record Dates|
|Last Update Posted:||November 13, 2019|
|Last Verified:||November 2019|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|