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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
Sponsor:
Information provided by (Responsible Party):
NuPulseCV

Brief Summary:
The purpose of this feasibility study is to assess the preliminary safety and clinical performance of the intravascular ventricular assist system (iVAS).

Condition or disease Intervention/treatment Phase
Heart Failure NYHA Class III Heart Failure NYHA Class IV Device: intravascular ventricular assist system (iVAS) Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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.
Other Names:
  • iVAS
  • Blood Pump
  • NuPulse




Primary Outcome Measures :
  1. Survival to transplant or stroke-free survival [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Number of patients who deteriorate requiring escalation of treatment [ Time Frame: 30 days ]
  2. Rate of occurrence of all adverse events [ Time Frame: 30 days ]
  3. Rate of occurrence of procedure-related adverse events [ Time Frame: 30 days ]
  4. Rate of occurrence of serious device-related adverse events [ Time Frame: 30 days ]
  5. Number of patients demonstrating improvement in NYHA Classification [ Time Frame: 30 days ]
  6. Number of patients demonstrating improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) - quality of life (QOL) [ Time Frame: 30 days ]
  7. Number of patients demonstrating improvement six minute walk test (6MWT) and two minute step test (2MST) [ Time Frame: 30 days ]
  8. Number of patients demonstrating improvement in Seattle Heart Failure Model Score [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Lori Rhoten 1-800-216-1778 CTT@nupulsecv.com

Locations
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United States, District of Columbia
MedStar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Ezequiel Molina         
United States, Florida
Advent Health Recruiting
Orlando, Florida, United States, 32804
Contact: Scott Silvestry         
United States, Illinois
University of Chicago Medicine Recruiting
Chicago, Illinois, United States, 60637
Contact: Colleen Juricek         
NorthShore University Health System Recruiting
Evanston, Illinois, United States, 60201
Contact: Robert Gordon         
United States, Indiana
Saint Vincent Hospital Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Christopher Salerno         
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Mark Slaughter         
United States, Louisiana
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Aditya Bansal         
United States, Massachusetts
Brigham & Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Michael Givertz         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Ranjit John         
United States, Missouri
Saint Luke's Mid-America Heart Institute Completed
Kansas City, Missouri, United States, 64111
United States, Nebraska
University of Nebraska Recruiting
Omaha, Nebraska, United States, 68198
Contact: John Um         
United States, New York
New York University Recruiting
New York, New York, United States, 10016
Contact: Deane Smith         
Columbia University Medical Center / New York-Presbyterian Hospital Recruiting
New York, New York, United States, 10032
Contact: Koji Takeda         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Carmelo Milano         
United States, Pennsylvania
Abington Hospital - Jefferson Health Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Donald Haas         
Penn State Health Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Robert Dowling         
United States, Texas
Houston Methodist Research Institute Recruiting
Houston, Texas, United States, 77030
Contact: Erik Suarez         
United States, Utah
University of Utah Hospital Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Craig Selzman         
Sponsors and Collaborators
NuPulseCV

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Responsible Party: NuPulseCV
ClinicalTrials.gov Identifier: NCT02645539     History of Changes
Other Study ID Numbers: PRO-10001
First Posted: January 1, 2016    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Keywords provided by NuPulseCV:
Heart failure
Bridge-to-transplant
circulatory support
VAD
IABP
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases