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VentrAssistTM LVAD for the Treatment of Advanced Heart Failure - Destination Therapy

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; detailed criteria are included in the study protocol):

  • Eligible for either the VentrAssist or an FDA-approved DT LVAD
  • LVEF <=25%
  • Stage D heart failure
  • Ineligible for cardiac transplantation
  • Treated with standard heart failure therapy

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

  • Contraindication to LVAD implantation
  • Contraindication to anticoagulant or anti-platelet agents.
  • Pre-existing mechanical circulatory support other than intra-aortic balloon pump
  • Therapy with an investigational intervention at the time of screening
  • A condition, other than heart failure, which would limit survival to less than 2 years

Sites / Locations

  • University of Alabama
  • Mayo Clinic
  • University of Florida
  • Jackson Memorial
  • Northwestern University
  • St. Vincent's
  • University of Maryland School of Medicine
  • University of Minnesota
  • 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
  • Ohio State University
  • Hospital of the University of Pennsylvania
  • Allegheny General Hospital
  • University of Pittsburgh Medical Center
  • 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

Module A: Survival without a disabling stroke.
Module B: A composite endpoint of disabling stroke-free survival without device replacement or repair due to failure of the device to provide adequate circulatory support.

Secondary Outcome Measures

•Safety •Functional Status and Hospitalizations •Quality of Life and Neurocognitive Assessment

Full Information

First Posted
June 20, 2007
Last Updated
September 4, 2009
Sponsor
Ventracor
Collaborators
International Center for Health Outcomes and Innovation Research
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1. Study Identification

Unique Protocol Identification Number
NCT00490321
Brief Title
VentrAssistTM LVAD for the Treatment of Advanced Heart Failure - Destination Therapy
Official Title
Evaluation of the VentrAssistTM Left Ventricular Assist Device for the Treatment of Advanced Heart Failure - Destination Therapy
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 2012 (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 LVADs in providing long-term circulatory support for patients who have chronic stage D heart failure and are ineligible for a heart transplant. This is a multi-center, prospective, randomized, controlled clinical trial, which is comprised of two independent modules.
Detailed Description
Currently, patients with Stage D heart failure who are not transplant candidates are treated with a spectrum of therapies, including specialized medical management as well as mechanical support with an LVAD approved by FDA for destination therapy. However, there is substantial variation in the therapeutic approaches employed to treat these patients, with relatively low numbers of patients receiving DT LVAD therapy to date. Therefore, the VentrAssist DT trial is designed to provide maximal flexibility to the investigators/clinicians to incorporate their clinical judgment in managing these complex patients.

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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
225 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
VentrAssistTM Left Ventricular Assist Device
Primary Outcome Measure Information:
Title
Module A: Survival without a disabling stroke.
Title
Module B: A composite endpoint of disabling stroke-free survival without device replacement or repair due to failure of the device to provide adequate circulatory support.
Secondary Outcome Measure Information:
Title
•Safety •Functional Status and Hospitalizations •Quality of Life and Neurocognitive Assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria (The following are general criteria; detailed criteria are included in the study protocol): Eligible for either the VentrAssist or an FDA-approved DT LVAD LVEF <=25% Stage D heart failure Ineligible for cardiac transplantation Treated with standard heart failure therapy Exclusion Criteria (The following are general criteria; detailed criteria are included in the study protocol): Contraindication to LVAD implantation Contraindication to anticoagulant or anti-platelet agents. Pre-existing mechanical circulatory support other than intra-aortic balloon pump Therapy with an investigational intervention at the time of screening A condition, other than heart failure, which would limit survival to less than 2 years
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
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
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
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
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
University of Pittsburgh Medical Center
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

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VentrAssistTM LVAD for the Treatment of Advanced Heart Failure - Destination Therapy

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