Feasibility Study of the Intravascular Ventricular Assist System (iVAS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02645539|
Recruitment Status : Recruiting
First Posted : January 1, 2016
Last Update Posted : November 13, 2019
|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 ]
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|