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

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
The Jarvik 2000 Ventricular Assist System
Sponsored by
Jarvik Heart, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 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.

Sites / Locations

  • University of Maryland Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Jarvik 2000 Ventricular Assist System

Arm Description

Jarvik 2000 Ventricular Assist System

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
December 26, 2007
Last Updated
September 20, 2013
Sponsor
Jarvik Heart, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00591799
Brief Title
Jarvik 2000 Heart as a Bridge to Cardiac Transplantation - Pivotal Trial
Official Title
Clinical Protocol for Evaluation of the Jarvik 2000 Heart Assist System
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jarvik Heart, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Jarvik 2000 Ventricular Assist System
Arm Type
Experimental
Arm Description
Jarvik 2000 Ventricular Assist System
Intervention Type
Device
Intervention Name(s)
The Jarvik 2000 Ventricular Assist System
Other Intervention Name(s)
Jarvik 2000
Intervention Description
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.
Primary Outcome Measure Information:
Title
Survival to cardiac transplantation or survival and transplant listed at 180 days following implant of the Jarvik 2000 Heart.
Time Frame
180 days
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Jarvik, MD
Organizational Affiliation
Jarvik Heart, Inc. SPONSOR
Official's Role
Study Chair
Facility Information:
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35421002
Citation
Selzman CH, Feller ED, Walker JC, Sheridan BC, Silvestry SC, Daly RC, Anyanwu AC, Madigan D, Liu PY, Frazier OH, Jorde UP, Griffith BP. The Jarvik 2000 Left Ventricular Assist Device: Results of the United States Bridge to Transplant Trial. ASAIO J. 2023 Feb 1;69(2):174-182. doi: 10.1097/MAT.0000000000001750. Epub 2022 Apr 13.
Results Reference
derived

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

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