Clinical trial NCT02645539: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure NYHA Class III
Heart Failure NYHA Class IV
Keywords: Heart failure
Bridge-to-transplant
circulatory support
VAD
IABP
Lead sponsor: NuPulseCV
Sponsor class: INDUSTRY
First posted: 2016-01-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Survival to transplant or stroke-free survival
timeFrame: 30 days
Secondary outcomes:
measure: Number of patients who deteriorate requiring escalation of treatment
timeFrame: 30 days
measure: Rate of occurrence of all adverse events
timeFrame: 30 days
measure: Rate of occurrence of procedure-related adverse events
timeFrame: 30 days
measure: Rate of occurrence of serious device-related adverse events
timeFrame: 30 days
measure: Number of patients demonstrating improvement in NYHA Classification
timeFrame: 30 days
measure: Number of patients demonstrating improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) - quality of life (QOL)
timeFrame: 30 days
measure: Number of patients demonstrating improvement six minute walk test (6MWT) and two minute step test (2MST)
timeFrame: 30 days
measure: Number of patients demonstrating improvement in Seattle Heart Failure Model Score
timeFrame: 30 days
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Orlando
country: United States
facility: Advent Health
state: Florida
city: Chicago
country: United States
facility: University of Chicago Medicine
state: Illinois
city: Evanston
country: United States
facility: NorthShore University Health System
state: Illinois
city: Indianapolis
country: United States
facility: Saint Vincent Hospital
state: Indiana
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Kansas City
country: United States
facility: Saint Luke's Mid-America Heart Institute
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska
state: Nebraska
city: New York
country: United States
facility: New York University
state: New York
city: New York
country: United States
facility: Columbia University Medical Center / New York-Presbyterian Hospital
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Abington
country: United States
facility: Abington Hospital - Jefferson Health
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Health Milton S. Hershey Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
Study officials:
References:
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.