Feasibility Study of the Intravascular Ventricular Assist System (iVAS)

Not Applicable

• Conditions: Heart Failure NYHA Class III; Heart Failure NYHA Class IV
• Interventions: Device: intravascular ventricular assist system (iVAS)

• Registration Number: NCT02645539
• Lead Sponsor: NuPulseCV

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 Timeline

• Study First Submitted: 2015-12-30
• Study First Submitted QC: 2015-12-31
• Study First Posted: 2016-01-01
• Study Start: 2016-04
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-11
• Last Update Posted: 2019-11-13
• Primary Completion: 2020-07
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	intravascular ventricular assist system (iVAS)	All patients are treated with the intravascular ventricular assist system (iVAS).

Primary Outcome Measures

Name	Time	Method
Survival to transplant or stroke-free survival	30 days

Secondary Outcome Measures

Name	Time	Method
Rate of occurrence of procedure-related adverse events	30 days
Number of patients demonstrating improvement six minute walk test (6MWT) and two minute step test (2MST)	30 days
Number of patients who deteriorate requiring escalation of treatment	30 days
Rate of occurrence of serious device-related adverse events	30 days
Number of patients demonstrating improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) - quality of life (QOL)	30 days
Number of patients demonstrating improvement in Seattle Heart Failure Model Score	30 days
Number of patients demonstrating improvement in NYHA Classification	30 days
Rate of occurrence of all adverse events	30 days

Trial Locations

Locations (18)

MedStar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Advent Health; 🇺🇸 Orlando, Florida, United States

University of Chicago Medicine; 🇺🇸 Chicago, Illinois, United States

NorthShore University Health System; 🇺🇸 Evanston, Illinois, United States

Saint Vincent Hospital; 🇺🇸 Indianapolis, Indiana, United States

University of Louisville; 🇺🇸 Louisville, Kentucky, United States

Ochsner Clinic Foundation; 🇺🇸 New Orleans, Louisiana, United States

Brigham & Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Saint Luke's Mid-America Heart Institute; 🇺🇸 Kansas City, Missouri, United States

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