VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Feasibility Trial

Sponsor

Ventracor (Industry)

Overall Status

Completed

CT.gov ID

NCT00490347

Collaborator

International Center for Health Outcomes and Innovation Research (Other)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
End-Stage Heart Failure Cardiomyopathies	Device: VentrAssist Left Ventricular Assist Device	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Evaluation of the VentrAssistTM Left Ventricular Assist Device as a Bridge to Cardiac Transplantation - Feasibility Trial

Study Start Date :

Jul 1, 2005

Actual Study Completion Date :

Oct 1, 2007

Outcome Measures

Primary Outcome Measures

Survival []

Secondary Outcome Measures

Quality of life []
Functional status []
Neurocognitive function []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Maryland Medical Center - Baltimore	Baltimore	Maryland	United States	21201
2	University of Minnesota Medical Center - Fairview	Minneapolis	Minnesota	United States	55455
3	New York Presbyterian Medical Center - Columbia	New York	New York	United States	10032
4	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
5	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213