search
Back to results

VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Pivotal Trial

Primary Purpose

End-stage Heart Failure, Cardiomyopathies

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
VentrAssistTM Left Ventricular Assist Device
Sponsored by
Ventracor
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-stage Heart Failure focused on measuring VentrAssistTM, LVAD, End-stage heart failure, Cardiomyopathy

Eligibility Criteria

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

Inclusion Criteria:(The following are general criteria; more specific criteria are included in the study protocol):

  • Approved and listed for cardiac transplantation.
  • Patient for whom LVAD implantation is planned as a clinically indicated bridge to cardiac transplantation.

Exclusion Criteria:(The following are general criteria; more specific criteria are included in the study protocol):

  • Presence of heart conditions that would contraindicate LVAD implantation by adversely affecting patient survival or LVAD function.
  • Primary coagulopathy or platelet disorder; contraindication to anticoagulant or anti-platelet agents.
  • Presence of any mechanical circulatory support other than intra-aortic balloon pump.
  • Therapy with an investigational intervention at the time of screening.

Sites / Locations

  • University of Alabama
  • Mayo Clinic
  • University of Florida
  • Jackson Memorial
  • Northwestern University
  • Rush University Medical Center
  • St. Vincent's
  • University of Maryland School of Medicine
  • University of Minnesota Medical Center
  • Mayo Clinic
  • Washington University School of Medicine
  • Newark Beth Israel Medical Center
  • Montefiore Medical Center
  • Mount Sinai Hospital
  • Columbia University
  • Rochester Medical Center University
  • Duke Medical Center
  • Cleveland Clinic
  • Ohio State University
  • Hospital of the University of Pennsylvania
  • Allegheny General Hospital
  • UPMC Presbyterian
  • Methodist Hospital
  • University of Utah
  • Fairfax (Inova) Hospital
  • University of Washington
  • Sacred Heart Medical Center
  • University of Wisconsin Hospital
  • St. Luke's Medical Center

Outcomes

Primary Outcome Measures

Survival to cardiac transplantation or to 180 days post implantation and listed for cardiac transplantation in categories UNOS 1A or 1B.

Secondary Outcome Measures

Quality of life
Functional status
Neurocognitive function

Full Information

First Posted
June 4, 2007
Last Updated
September 4, 2009
Sponsor
Ventracor
Collaborators
International Center for Health Outcomes and Innovation Research
search

1. Study Identification

Unique Protocol Identification Number
NCT00483197
Brief Title
VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Pivotal Trial
Official Title
Evaluation of the VentrAssistTM Left Ventricular Assist Device as a Bridge to Cardiac Transplantation - Pivotal Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
June 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Ventracor
Collaborators
International Center for Health Outcomes and Innovation Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of VentrAssistTM LVAD in individuals who are awaiting heart transplants.
Detailed Description
LVADs are efficacious in improving survival and functional status when used as a bridge to transplantation. The purpose of this study is to evaluate the safety and effectiveness of the VentrAssist LVAD in providing circulatory support in individuals who are awaiting heart transplants. The VentrAssist LVAD is a centrifugal flow pump. Its small size and mechanical simplicity offers benefits not available with currently approved LVADs, including facilitating a more limited implantation procedure, which could reduce surgical morbidity and mortality.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Heart Failure, Cardiomyopathies
Keywords
VentrAssistTM, LVAD, End-stage heart failure, Cardiomyopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
VentrAssistTM Left Ventricular Assist Device
Primary Outcome Measure Information:
Title
Survival to cardiac transplantation or to 180 days post implantation and listed for cardiac transplantation in categories UNOS 1A or 1B.
Secondary Outcome Measure Information:
Title
Quality of life
Title
Functional status
Title
Neurocognitive function

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:(The following are general criteria; more specific criteria are included in the study protocol): Approved and listed for cardiac transplantation. Patient for whom LVAD implantation is planned as a clinically indicated bridge to cardiac transplantation. Exclusion Criteria:(The following are general criteria; more specific criteria are included in the study protocol): Presence of heart conditions that would contraindicate LVAD implantation by adversely affecting patient survival or LVAD function. Primary coagulopathy or platelet disorder; contraindication to anticoagulant or anti-platelet agents. Presence of any mechanical circulatory support other than intra-aortic balloon pump. Therapy with an investigational intervention at the time of screening.
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Mayo Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Jackson Memorial
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
St. Vincent's
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
University of Maryland School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Minnesota Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55904
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Rochester Medical Center University
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Duke Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
UPMC Presbyterian
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Fairfax (Inova) Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98185
Country
United States
Facility Name
Sacred Heart Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
University of Wisconsin Hospital
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Pivotal Trial

We'll reach out to this number within 24 hrs