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Clinical Trials/NCT00490347
NCT00490347CompletedPhase 2

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

Ventracor9 sites in 1 country30 target enrollmentStarted: July 1, 2005Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
30
Locations
9
Primary Endpoint
Survival
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Survival

Secondary Outcomes

  • Neurocognitive function
  • Quality of life
  • Functional status

Investigators

Sponsor
Ventracor
Sponsor Class
Industry

Study Sites (9)

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VentrAssistTM LVAD as a Bridge to Cardiac... | Clinical Trial