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Feasibility Study of the Intravascular Ventricular Assist System (iVAS)

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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

Tracking Information
First Submitted Date  ICMJE December 30, 2015
First Posted Date  ICMJE January 1, 2016
Last Update Posted Date November 13, 2019
Actual Study Start Date  ICMJE April 2016
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2018)
Survival to transplant or stroke-free survival [ Time Frame: 30 days ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT02645539 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2018)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility Study of the Intravascular Ventricular Assist System (iVAS)
Official Title  ICMJE A Clinical Study to Evaluate Ambulatory Counterpulsation for the Treatment of Advanced Heart Failure: A Feasibility Study
Brief Summary The purpose of this feasibility study is to assess the preliminary safety and clinical performance of the intravascular ventricular assist system (iVAS).
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Heart Failure NYHA Class III
  • Heart Failure NYHA Class IV
Intervention  ICMJE Device: intravascular ventricular assist system (iVAS)
A mechanical circulatory support device using the principles of counterpulsation.
Other Names:
  • iVAS
  • Blood Pump
  • NuPulse
Study Arms  ICMJE Experimental: Single Arm
All patients are treated with the intravascular ventricular assist system (iVAS).
Intervention: Device: intravascular ventricular assist system (iVAS)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 2, 2018)
100
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lori Rhoten 1-800-216-1778 CTT@nupulsecv.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02645539
Other Study ID Numbers  ICMJE PRO-10001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NuPulseCV
Study Sponsor  ICMJE NuPulseCV
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account NuPulseCV
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP