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

Study Overview
=================
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.

Official Title
-----------------
Clinical Protocol for Evaluation of the Jarvik 2000 Heart Assist System

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: The Jarvik 2000 Ventricular Assist System


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jarvik 2000 Ventricular Assist System<br>Jarvik 2000 Ventricular Assist System | Device: The Jarvik 2000 Ventricular Assist System<br>* 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.<br>* Other names: Jarvik 2000;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival to cardiac transplantation or survival and transplant listed at 180 days following implant of the Jarvik 2000 Heart. |  | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |