Heart Failure NYHA Class IIINCT02645539
Feasibility Study of the Intravascular Ventricular Assist System (iVAS)
A study testing intravascular ventricular assist system (iVAS) in people with Heart Failure NYHA Class III and Heart Failure NYHA Class IV, run by NuPulseCV at 18 sites in United States.
Trial summary
The purpose of this feasibility study is to assess the preliminary safety and clinical performance of the intravascular ventricular assist system (iVAS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure NYHA Class III, Heart Failure NYHA Class IV
- What is being tested?
- intravascular ventricular assist system (iVAS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 18 sitesUnited States
- Study dates
- Apr 2016to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites, 17 recruiting
- Recruiting
Abington Hospital - Jefferson Health
Abington, Pennsylvania, 19001
Donald Haas
- Recruiting
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Michael Givertz
- Recruiting
University of Chicago Medicine
Chicago, Illinois, 60637
Colleen Juricek
- Recruiting
Duke University
Durham, North Carolina, 27710
Carmelo Milano
- Recruiting
NorthShore University Health System
Evanston, Illinois, 60201
Robert Gordon
- Recruiting
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Robert Dowling
- Recruiting
Houston Methodist Research Institute
Houston, Texas, 77030
Erik Suarez
- Recruiting
Saint Vincent Hospital
Indianapolis, Indiana, 46260
Christopher Salerno
- Completed
Saint Luke's Mid-America Heart Institute
Kansas City, Missouri, 64111
- Recruiting
University of Louisville
Louisville, Kentucky, 40202
Mark Slaughter
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Ranjit John
- Recruiting
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Aditya Bansal
- Recruiting
New York University
New York, New York, 10016
Deane Smith
- Recruiting
Columbia University Medical Center / New York-Presbyterian Hospital
New York, New York, 10032
Koji Takeda
- Recruiting
University of Nebraska
Omaha, Nebraska, 68198
John Um
- Recruiting
Advent Health
Orlando, Florida, 32804
Scott Silvestry
- Recruiting
University of Utah Hospital
Salt Lake City, Utah, 84132
Craig Selzman
- Recruiting
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Ezequiel Molina
About this study
Official title: A Clinical Study to Evaluate Ambulatory Counterpulsation for the Treatment of Advanced Heart Failure: A Feasibility Study
The purpose of this feasibility study is to assess the preliminary safety and clinical performance of the intravascular ventricular assist system (iVAS).
Read the 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.
- Being tested
- intravascular ventricular assist system (iVAS)
- Keywords
- Heart failure, Bridge-to-transplant, circulatory support, VAD, IABP
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravascular ventricular assist system (iVAS)Device
Also called iVAS, Blood Pump, NuPulse
A mechanical circulatory support device using the principles of counterpulsation.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | All patients are treated with the intravascular ventricular assist system (iVAS). Receives: Device: intravascular ventricular assist system (iVAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival to transplant or stroke-free survival
Measured: 30 days
Secondary outcomes (8)
Number of patients who deteriorate requiring escalation of treatment
Measured: 30 days
Rate of occurrence of all adverse events
Measured: 30 days
Rate of occurrence of procedure-related adverse events
Measured: 30 days
Rate of occurrence of serious device-related adverse events
Measured: 30 days
Number of patients demonstrating improvement in NYHA Classification
Measured: 30 days
Number of patients demonstrating improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) - quality of life (QOL)
Measured: 30 days
Number of patients demonstrating improvement six minute walk test (6MWT) and two minute step test (2MST)
Measured: 30 days
Number of patients demonstrating improvement in Seattle Heart Failure Model Score
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study startApr 2016
- Primary completionJul 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure NYHA Class IIIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NuPulseCV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645539
- Sponsor's protocol ID
- PRO-10001
- Status last verified
- Nov 2019
- First submitted
- 30 Dec 2015
- Last updated
- 13 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 32264715
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate Ambulatory Counterpulsation for the Treatment of Advanced Heart Failure: A Feasibility Study
- ClinicalTrials.gov ID
- NCT02645539
- Acronym / sponsor ID
- PRO-10001
- Keywords
- Heart failure, Bridge-to-transplant, circulatory support, VAD, IABP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- NuPulseCVIndustry (pharma, biotech, devices)
- Study start
- Apr 2016 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 1 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Device: intravascular ventricular assist system (iVAS)All patients are treated with the intravascular ventricular assist system (iVAS). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravascular ventricular assist system (iVAS)Also: iVAS, Blood Pump, NuPulseA mechanical circulatory support device using the principles of counterpulsation. | Device | Single Arm |
Primary outcome
Survival to transplant or stroke-free survival
Time frame: 30 days
8 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Derived from this study: PubMed 32264715Uriel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intravascular ventricular assist system (iVAS) in people with Heart Failure NYHA Class III and Heart Failure NYHA Class IV, run by NuPulseCV at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lori Rhoten (1-800-216-1778, CTT@nupulsecv.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival to transplant or stroke-free survival (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02645539, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2019.