Voyager I: Patient Discharge Using the AB5000 Portable Driver System

May 1, 2013 updated by: Abiomed Inc.
The AB Portable Driver System will allow patients supported with the Circulatory Support System to be discharged home when their medical condition improves to an ambulating status and will continue to receive the assistance of the AB 5000 ventricle for their heart recovery.

Study Overview

Status

Terminated

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The subject is an AB5000 Circulatory Support System patient (in accordance FDA-approved indications for use) who is suffering acute cardiac dysfunction and is potentially recoverable;
  • The subject is male or female, age 18 years or older;
  • The subject is able to ambulate unassisted;
  • The subject is on stable oral anticoagulation over 7 days (INR 2-4) with no active bleeding;
  • The subject is willing and able to read, understand and sign the study specific informed consent form;
  • The subject agrees to comply with study protocol requirements, including all follow-up visits and completion of Qol and NIH stroke scale assessments.

Exclusion Criteria:

  • The subject, pre-device implant, is qualified as a transplant candidate.
  • There is an absence of a trained companion.
  • There is an absence of a psycho-social support.
  • The subject has an inadequate home environment, such as poor access which may hinder movements.
  • The subject has experienced hypotension in last 24 hours based on two consecutive readings spaced by 8 hours with systolic blood pressures < 90 mmHg.
  • The subject requires respiratory assistance.
  • The subject has an active infection (positive blood culture and/or body T ≥ 38 degrees C, and/or WBC ≥ 12K/µL).
  • The subject requires tube feeding.
  • The subject has any other medical condition requiring hospitalization.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events, Quality of life assessment, NIH Stroke Scale Assessments, and patient outcome after readmission
Time Frame: Pre-discharge, 30 days post-discharge, 90 days or re-admission
Pre-discharge, 30 days post-discharge, 90 days or re-admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

April 1, 2013

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

September 2, 2009

First Submitted That Met QC Criteria

September 3, 2009

First Posted (Estimate)

September 4, 2009

Study Record Updates

Last Update Posted (Estimate)

May 3, 2013

Last Update Submitted That Met QC Criteria

May 1, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • Voyager I: G80013/S001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Cardiac Dysfunction

Clinical Trials on AB Portable Driver System

3
Subscribe