Feasibility Study of the Intravascular Ventricular Assist System (iVAS)

Heart Failure NYHA Class III Clinical Trial

Official title:

A Clinical Study to Evaluate Ambulatory Counterpulsation for the Treatment of Advanced Heart Failure: A Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02645539
• Other study ID #: PRO-10001
• Status: Recruiting
• Phase: N/A
• Start date: April 2016
• Est. completion date: December 2020

Study information

• Verified date: November 2019
• Source: NuPulseCV
• Contact: Lori Rhoten
• Phone: 1-800-216-1778
• Email: CTT[@]nupulsecv.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this feasibility study is to assess the preliminary safety and clinical performance of the intravascular ventricular assist system (iVAS).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure NYHA Class III
• Heart Failure NYHA Class IV

Intervention

Device:
• intravascular ventricular assist system (iVAS)
A mechanical circulatory support device using the principles of counterpulsation.

Locations

Country	Name	City	State
United States	Abington Hospital - Jefferson Health	Abington	Pennsylvania
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	University of Chicago Medicine	Chicago	Illinois
United States	Duke University	Durham	North Carolina
United States	NorthShore University Health System	Evanston	Illinois
United States	Penn State Health Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Houston Methodist Research Institute	Houston	Texas
United States	Saint Vincent Hospital	Indianapolis	Indiana
United States	Saint Luke's Mid-America Heart Institute	Kansas City	Missouri
United States	University of Louisville	Louisville	Kentucky
United States	University of Minnesota	Minneapolis	Minnesota
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Columbia University Medical Center / New York-Presbyterian Hospital	New York	New York
United States	New York University	New York	New York
United States	University of Nebraska	Omaha	Nebraska
United States	Advent Health	Orlando	Florida
United States	University of Utah Hospital	Salt Lake City	Utah
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
NuPulseCV

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival to transplant or stroke-free survival		30 days
Secondary	Number of patients who deteriorate requiring escalation of treatment		30 days
Secondary	Rate of occurrence of all adverse events		30 days
Secondary	Rate of occurrence of procedure-related adverse events		30 days
Secondary	Rate of occurrence of serious device-related adverse events		30 days
Secondary	Number of patients demonstrating improvement in NYHA Classification		30 days
Secondary	Number of patients demonstrating improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) - quality of life (QOL)		30 days
Secondary	Number of patients demonstrating improvement six minute walk test (6MWT) and two minute step test (2MST)		30 days
Secondary	Number of patients demonstrating improvement in Seattle Heart Failure Model Score		30 days