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

September 20, 2013 updated by: Jarvik Heart, Inc.

Clinical Protocol for Evaluation of the Jarvik 2000 Heart Assist System

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Jarvik 2000 Heart is a silent compact axial flow impeller pump of 1 inch diameter, weighing 90g with a displacement volume of 25ml. The pump is implanted into the apex of the left ventricle by left thoracotomy, or by mid-sternotomy, or by the subcostal approach. A vascular graft offloads to either the descending thoracic aorta, the ascending thoracic aorta, or the abdominal aorta. The impeller rotates at speeds of 8,000 to 12,000 rpm providing blood flow of up to seven L/minute. At higher speeds the pump can produce 10 L/minute. Power is provided through an abdominal drive line.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: (The following are general inclusion criteria; more specific criteria are outlined in the study protocol).

  • Transplant listed UNOS status IA or IB patients.
  • BSA >1.5 m2 and <2.3 m2.
  • Dependent on one or more intravenous inotropic agents or an intraaortic balloon pump (IABP).

Exclusion Criteria:(The following are general exclusion criteria; more specific criteria are outlined in the study protocol).

  • Known risk factors or conditions that would contraindicate LVAD implantation or adversely affect patient survival.
  • Evidence of end organ dysfunction.
  • Known coagulopathy or contraindication of anticoagulation or antiplatelet agents.
  • Systemic infection.
  • Malignancies not in remission.
  • Current participation in investigational trials with other devices, drugs, or biologic agents.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Jarvik 2000 Ventricular Assist System
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.
Other Names:
  • Jarvik 2000

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival to cardiac transplantation or survival and transplant listed at 180 days following implant of the Jarvik 2000 Heart.
Time Frame: 180 days
180 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of serious adverse events as events per patient month including infection, stroke, VAD failure, and all serious adverse events. Quality of Life measures - MLHFQ, NYHA class, Neurocognitive assessments.
Time Frame: 180 days
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jarvik Heart, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

December 29, 2007

First Posted (Estimate)

January 11, 2008

Study Record Updates

Last Update Posted (Estimate)

September 27, 2013

Last Update Submitted That Met QC Criteria

September 20, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G000058

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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