NCT00490347

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2005

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

January 17, 2008

Status Verified

January 1, 2008

First QC Date

June 20, 2007

Last Update Submit

January 15, 2008

Conditions

End-Stage Heart FailureCardiomyopathies

Keywords

VentrAssistTMLVADEnd-stage heart failureCardiomyopathy

Outcome Measures

Primary Outcomes (1)

  • Survival

Secondary Outcomes (3)

  • Quality of life

  • Functional status

  • Neurocognitive function

Interventions

VentrAssist Left Ventricular Assist DeviceDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Maryland Medical Center - Baltimore

Baltimore, Maryland, 21201, United States

Location

University of Minnesota Medical Center - Fairview

Minneapolis, Minnesota, 55455, United States

Location

New York Presbyterian Medical Center - Columbia

New York, New York, 10032, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 20, 2007

First Posted

June 22, 2007

Study Start

July 1, 2005

Study Completion

October 1, 2007

Last Updated

January 17, 2008

Record last verified: 2008-01

Locations

US(5)