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VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Feasibility Trial

Primary Purpose

End-Stage Heart Failure, Cardiomyopathies

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VentrAssist 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 Maryland Medical Center - Baltimore
  • University of Minnesota Medical Center - Fairview
  • New York Presbyterian Medical Center - Columbia
  • Cleveland Clinic Foundation
  • University of Pittsburgh Medical Center

Outcomes

Primary Outcome Measures

Survival

Secondary Outcome Measures

Quality of life
Functional status
Neurocognitive function

Full Information

First Posted
June 20, 2007
Last Updated
January 15, 2008
Sponsor
Ventracor
Collaborators
International Center for Health Outcomes and Innovation Research
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1. Study Identification

Unique Protocol Identification Number
NCT00490347
Brief Title
VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Feasibility Trial
Official Title
Evaluation of the VentrAssistTM Left Ventricular Assist Device as a Bridge to Cardiac Transplantation - Feasibility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)

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 trial is to determine the safety and feasibility of the VentrAssist LVAD in providing circulatory support for patients who require an LVAD as a bridge to cardiac transplantation.

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 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
VentrAssist Left Ventricular Assist Device
Primary Outcome Measure Information:
Title
Survival
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 Maryland Medical Center - Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Minnesota Medical Center - Fairview
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
New York Presbyterian Medical Center - Columbia
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

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