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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00591799
First Posted: January 11, 2008
Last Update Posted: September 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jarvik Heart, Inc.
  Purpose
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.

Condition Intervention Phase
Heart Failure Device: The Jarvik 2000 Ventricular Assist System Phase 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Protocol for Evaluation of the Jarvik 2000 Heart Assist System

Resource links provided by NLM:


Further study details as provided by Jarvik Heart, Inc.:

Primary Outcome 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 Outcome 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 ]

Enrollment: 150
Study Start Date: April 2005
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Jarvik 2000 Ventricular Assist System
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 Name: Jarvik 2000

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00591799


Locations
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Jarvik Heart, Inc.
Investigators
Study Chair: Robert Jarvik, MD Jarvik Heart, Inc. SPONSOR
  More Information

Responsible Party: Jarvik Heart, Inc.
ClinicalTrials.gov Identifier: NCT00591799     History of Changes
Other Study ID Numbers: G000058
First Submitted: December 26, 2007
First Posted: January 11, 2008
Last Update Posted: September 27, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases


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