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Jarvik 2000 Heart as a Bridge to Cardiac Transplantation - Pivotal Trial

NCT00591799 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2013-09-27

No results posted yet for this study

Summary

The purpose of the study is to determine the safety and effectiveness of the Jarvik 2000 Heart as a bridge to heart transplantation in end-stage heart failure patients who are approved heart transplant candidates.

Conditions

Interventions

DEVICE

The Jarvik 2000 Ventricular Assist System

Jarvik 2000 Heart implantation is intended for patient's with end-stage heart failure who are approved heart transplant candidates - who meet all of the study's inclusion criteria and none of its exclusion criteria.

Sponsors & Collaborators

  • Jarvik Heart, Inc.

    lead INDUSTRY

Principal Investigators

  • Robert Jarvik, MD · Jarvik Heart, Inc. SPONSOR

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00591799 on ClinicalTrials.gov