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Feasibility Study of the Intravascular Ventricular Assist System (iVAS)

Primary Purpose

Heart Failure NYHA Class III, Heart Failure NYHA Class IV

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
intravascular ventricular assist system (iVAS)
Sponsored by
NuPulseCV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure NYHA Class III focused on measuring Heart failure, Bridge-to-transplant, circulatory support, VAD, IABP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • MedStar Washington Hospital CenterRecruiting
  • Advent HealthRecruiting
  • University of Chicago MedicineRecruiting
  • NorthShore University Health SystemRecruiting
  • Saint Vincent HospitalRecruiting
  • University of LouisvilleRecruiting
  • Ochsner Clinic FoundationRecruiting
  • Brigham & Women's HospitalRecruiting
  • University of MinnesotaRecruiting
  • Saint Luke's Mid-America Heart Institute
  • University of NebraskaRecruiting
  • New York UniversityRecruiting
  • Columbia University Medical Center / New York-Presbyterian HospitalRecruiting
  • Duke UniversityRecruiting
  • Abington Hospital - Jefferson HealthRecruiting
  • Penn State Health Milton S. Hershey Medical CenterRecruiting
  • Houston Methodist Research InstituteRecruiting
  • University of Utah HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

All patients are treated with the intravascular ventricular assist system (iVAS).

Outcomes

Primary Outcome Measures

Survival to transplant or stroke-free survival

Secondary Outcome Measures

Number of patients who deteriorate requiring escalation of treatment
Rate of occurrence of all adverse events
Rate of occurrence of procedure-related adverse events
Rate of occurrence of serious device-related adverse events
Number of patients demonstrating improvement in NYHA Classification
Number of patients demonstrating improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) - quality of life (QOL)
Number of patients demonstrating improvement six minute walk test (6MWT) and two minute step test (2MST)
Number of patients demonstrating improvement in Seattle Heart Failure Model Score

Full Information

First Posted
December 30, 2015
Last Updated
November 11, 2019
Sponsor
NuPulseCV
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1. Study Identification

Unique Protocol Identification Number
NCT02645539
Brief Title
Feasibility Study of the Intravascular Ventricular Assist System (iVAS)
Official Title
A Clinical Study to Evaluate Ambulatory Counterpulsation for the Treatment of Advanced Heart Failure: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (Actual)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NuPulseCV

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure NYHA Class III, Heart Failure NYHA Class IV
Keywords
Heart failure, Bridge-to-transplant, circulatory support, VAD, IABP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Experimental
Arm Description
All patients are treated with the intravascular ventricular assist system (iVAS).
Intervention Type
Device
Intervention Name(s)
intravascular ventricular assist system (iVAS)
Other Intervention Name(s)
iVAS, Blood Pump, NuPulse
Intervention Description
A mechanical circulatory support device using the principles of counterpulsation.
Primary Outcome Measure Information:
Title
Survival to transplant or stroke-free survival
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Number of patients who deteriorate requiring escalation of treatment
Time Frame
30 days
Title
Rate of occurrence of all adverse events
Time Frame
30 days
Title
Rate of occurrence of procedure-related adverse events
Time Frame
30 days
Title
Rate of occurrence of serious device-related adverse events
Time Frame
30 days
Title
Number of patients demonstrating improvement in NYHA Classification
Time Frame
30 days
Title
Number of patients demonstrating improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) - quality of life (QOL)
Time Frame
30 days
Title
Number of patients demonstrating improvement six minute walk test (6MWT) and two minute step test (2MST)
Time Frame
30 days
Title
Number of patients demonstrating improvement in Seattle Heart Failure Model Score
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lori Rhoten
Phone
1-800-216-1778
Email
CTT@nupulsecv.com
Facility Information:
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ezequiel Molina
Facility Name
Advent Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Silvestry
Facility Name
University of Chicago Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colleen Juricek
Facility Name
NorthShore University Health System
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Gordon
Facility Name
Saint Vincent Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Salerno
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Slaughter
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aditya Bansal
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Givertz
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ranjit John
Facility Name
Saint Luke's Mid-America Heart Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Completed
Facility Name
University of Nebraska
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Um
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deane Smith
Facility Name
Columbia University Medical Center / New York-Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koji Takeda
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmelo Milano
Facility Name
Abington Hospital - Jefferson Health
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donald Haas
Facility Name
Penn State Health Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Dowling
Facility Name
Houston Methodist Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erik Suarez
Facility Name
University of Utah Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Craig Selzman

12. IPD Sharing Statement

Citations:
PubMed Identifier
32264715
Citation
Uriel N, Jeevanandam V, Imamura T, Onsager D, Song T, Ota T, Juricek C, Combs P, Lammy T, Patel-Raman S, Woolley JR, Sayer G, Milano C, Schroder J, Molina E, Grinstein J, Suarez E, Estep JD, Aggarwal S, Silvestry S, Raval N; iVAS Investigators. Clinical Outcomes and Quality of Life With an Ambulatory Counterpulsation Pump in Advanced Heart Failure Patients: Results of the Multicenter Feasibility Trial. Circ Heart Fail. 2020 Apr;13(4):e006666. doi: 10.1161/CIRCHEARTFAILURE.119.006666. Epub 2020 Apr 8.
Results Reference
derived

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Feasibility Study of the Intravascular Ventricular Assist System (iVAS)

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