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

Overview

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.

Full Title of Study: “Clinical Protocol for Evaluation of the Jarvik 2000 Heart Assist System”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2012

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.

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.

Arms, Groups and Cohorts

  • Experimental: Jarvik 2000 Ventricular Assist System
    • Jarvik 2000 Ventricular Assist System

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jarvik Heart, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Robert Jarvik, MD, Study Chair, Jarvik Heart, Inc. SPONSOR

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