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Feasibility Study of the Intravascular Ventricular Assist System (iVAS)

NCT02645539 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-11-13

No results posted yet for this study

Summary

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

Conditions

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

Interventions

DEVICE

intravascular ventricular assist system (iVAS)

A mechanical circulatory support device using the principles of counterpulsation.

Sponsors & Collaborators

  • NuPulseCV

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2020-07-31
Completion
2020-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02645539 on ClinicalTrials.gov