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Completed

NCT Number: NCT00591799

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The Jarvik 2000 Ventricular Assist System

Device

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

Primary outcomes

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

    Time frame: 180 days

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Jarvik Heart, Inc.

Industry

Registry information

Official study title

Clinical Protocol for Evaluation of the Jarvik 2000 Heart Assist System

Important dates

Study start
2005
Primary completion
2012
Study completion
2012
First posted
Jan 11, 2008
Registry last updated
Sep 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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