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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. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
NuPulseCV

Study Description
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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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
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

Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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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.
Contacts and Locations
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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
Show Show 18 study locations
Sponsors and Collaborators
NuPulseCV
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: NuPulseCV
ClinicalTrials.gov Identifier: NCT02645539    
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
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