VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Feasibility Trial

Cardiomyopathies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00490347
• Other study ID #: CLP070012
• Status: Completed
• Phase: Phase 2
• First received: June 20, 2007
• Last updated: January 15, 2008
• Start date: July 2005
• Est. completion date: October 2007

Study information

• Verified date: January 2008
• Source: Ventracor
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomyopathies
• End-Stage Heart Failure
• Heart Failure

Intervention

Device:
• VentrAssist Left Ventricular Assist Device

Locations

Country	Name	City	State
United States	University of Maryland Medical Center - Baltimore	Baltimore	Maryland
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	University of Minnesota Medical Center - Fairview	Minneapolis	Minnesota
United States	New York Presbyterian Medical Center - Columbia	New York	New York
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Ventracor	International Center for Health Outcomes and Innovation Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival
Secondary	Quality of life
Secondary	Functional status
Secondary	Neurocognitive function