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

Clinical Protocol for Evaluation of the Jarvik 2000 Heart Assist System

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00591799

Enrollment

150

Registered

2008-01-11

Start date

2005-04-30

Completion date

2012-05-31

Last updated

2013-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Brief summary

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.

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

DEVICEThe 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	180 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026