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

Phase 2

Completed

• Conditions: Heart Failure
• Interventions: Device: The Jarvik 2000 Ventricular Assist System

• Registration Number: NCT00591799
• Lead Sponsor: Jarvik Heart, Inc.

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.

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2007-12-26
• Study First Submitted QC: 2007-12-29
• Study First Posted: 2008-01-11
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2013-09
• Disposition First Submitted: 2013-09-18
• Disposition First Submitted QC: 2013-09-20
• Last Update Submitted: 2013-09-20
• Disposition First Posted: 2013-09-27
• Last Update Posted: 2013-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Jarvik 2000 Ventricular Assist System	The Jarvik 2000 Ventricular Assist System	Jarvik 2000 Ventricular Assist System

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States