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

NuPulseCV18 sites in 1 country100 target enrollmentApril 2016

ConditionsHeart Failure NYHA Class III Heart Failure NYHA Class IV

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Failure NYHA Class III
Sponsor: NuPulseCV
Enrollment: 100
Locations: 18
Primary Endpoint: Survival to transplant or stroke-free survival
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2016

End Date

December 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

NuPulseCV

Responsible Party

Sponsor

Eligibility Criteria

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)

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.

Outcomes

Primary Outcomes

Survival to transplant or stroke-free survival

Time Frame: 30 days

Secondary Outcomes

Rate of occurrence of all adverse events(30 days)
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)