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OpenTrials
Completed

NCT Number: NCT00490347

VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Feasibility Trial

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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Key information

Conditions

End-stage Heart Failure Cardiomyopathies Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Maryland Medical Center - Baltimore, Baltimore, Maryland, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VentrAssist Left Ventricular Assist Device

Device

Primary outcomes

  1. Survival

Secondary outcomes

  1. Quality of life

  2. Functional status

  3. Neurocognitive function

Sponsors and collaborators

Lead sponsor

Ventracor

Industry

Collaborators

  • International Center for Health Outcomes and Innovation Research

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2007
First posted
Jun 22, 2007
Registry last updated
Jan 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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