VentrAssistTM LVAD as a Bridge to Cardiac Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2007-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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End-Stage Heart Failure Cardiomyopathies

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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VentrAssist Left Ventricular Assist Device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No