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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jarvik Heart, Inc.
ClinicalTrials.gov Identifier:
NCT00591799
First received: December 26, 2007
Last updated: September 20, 2013
Last verified: September 2013
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Jarvik Heart, Inc.
ClinicalTrials.gov Identifier: NCT00591799     History of Changes
Other Study ID Numbers: G000058
Study First Received: December 26, 2007
Last Updated: September 20, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014