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A Clinical Trial to Evaluate the HeartWare® Ventricular Assist System

Study:

A Prospective, Randomized, Controlled, Un-blinded, Multi-Center Clinical Trial to Evaluate the HeartWare® Ventricular Assist System (VAS) for Destination Therapy of Advanced Heart Failure

Rationale:

n/a

Purpose:

The purpose of this study is to determine the safety and effectiveness of the HeartWare Ventricular Assist System in patients with chronic Stage D/NYHA Class IIIB/IV left ventricular failure who have received and failed optimal medical therapy, and who are ineligible for cardiac transplantation.

Study Status: Active, not recruiting

Recruiting:
n/a

Condition Intervention Phase
Chronic Heart Failure Device: HeartWare® VAS
Device: Control LVAD
N/A

Verified by HeartWare, Inc. January, 2014

Sponsored by: HeartWare, Inc.
Information provided by: HeartWare, Inc.
ClinicalTrials.gov identifier: NCT01166347

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States

Francis Pagani, MD., Principal Investigator
Joseph Rogers, MD., Principal Investigator

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

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