Feasibility Study of the Intravascular Ventricular Assist System (iVAS)
A Clinical Study to Evaluate Ambulatory Counterpulsation for the Treatment of Advanced Heart Failure: A Feasibility Study
1 other identifier
interventional
100
1 country
18
Brief Summary
The purpose of this feasibility study is to assess the preliminary safety and clinical performance of the intravascular ventricular assist system (iVAS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2016
Longer than P75 for not_applicable
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 30, 2015
CompletedFirst Posted
Study publicly available on registry
January 1, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedNovember 13, 2019
November 1, 2019
4.3 years
December 30, 2015
November 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival to transplant or stroke-free survival
30 days
Secondary Outcomes (8)
Number of patients who deteriorate requiring escalation of treatment
30 days
Rate of occurrence of all adverse events
30 days
Rate of occurrence of procedure-related adverse events
30 days
Rate of occurrence of serious device-related adverse events
30 days
Number of patients demonstrating improvement in NYHA Classification
30 days
- +3 more secondary outcomes
Study Arms (1)
Single Arm
EXPERIMENTALAll patients are treated with the intravascular ventricular assist system (iVAS).
Interventions
A mechanical circulatory support device using the principles of counterpulsation.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NuPulseCVlead
Study Sites (18)
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Advent Health
Orlando, Florida, 32804, United States
University of Chicago Medicine
Chicago, Illinois, 60637, United States
NorthShore University Health System
Evanston, Illinois, 60201, United States
Saint Vincent Hospital
Indianapolis, Indiana, 46260, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Saint Luke's Mid-America Heart Institute
Kansas City, Missouri, 64111, United States
University of Nebraska
Omaha, Nebraska, 68198, United States
New York University
New York, New York, 10016, United States
Columbia University Medical Center / New York-Presbyterian Hospital
New York, New York, 10032, United States
Duke University
Durham, North Carolina, 27710, United States
Abington Hospital - Jefferson Health
Abington, Pennsylvania, 19001, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Houston Methodist Research Institute
Houston, Texas, 77030, United States
University of Utah Hospital
Salt Lake City, Utah, 84132, United States
Related Publications (1)
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.
PMID: 32264715DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 30, 2015
First Posted
January 1, 2016
Study Start
April 1, 2016
Primary Completion
July 1, 2020
Study Completion
December 1, 2020
Last Updated
November 13, 2019
Record last verified: 2019-11