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

December 26, 2007
September 20, 2013
April 2005
May 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00591799 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Jarvik 2000 Heart as a Bridge to Cardiac Transplantation - Pivotal Trial
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.

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.

Interventional
Phase 2
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Failure
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
Experimental: Jarvik 2000 Ventricular Assist System
Jarvik 2000 Ventricular Assist System
Intervention: Device: The Jarvik 2000 Ventricular Assist System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
May 2012
May 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00591799
G000058
Yes
Jarvik Heart, Inc.
Jarvik Heart, Inc.
Not Provided
Study Chair: Robert Jarvik, MD Jarvik Heart, Inc. SPONSOR
Jarvik Heart, Inc.
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP