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Voyager I: Patient Discharge Using the AB5000 Portable Driver System

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ClinicalTrials.gov Identifier: NCT00971776
Recruitment Status : Terminated (Terminated due to slow enrollment and change in business priority)
First Posted : September 4, 2009
Last Update Posted : May 3, 2013
Sponsor:
Information provided by (Responsible Party):
Abiomed Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Cardiac Dysfunction Device: AB Portable Driver System Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Voyager I: Patient Discharge Using the AB5000 Portable Driver System
Study Start Date : June 2008
Actual Primary Completion Date : April 2013
Estimated Study Completion Date : September 2013

Intervention Details:
    Device: AB Portable Driver System
    Evaluate the safety and performance of the AB Portable Driver System in home environment.


Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Responsible Party: Abiomed Inc.
ClinicalTrials.gov Identifier: NCT00971776     History of Changes
Other Study ID Numbers: Voyager I: G80013/S001
First Posted: September 4, 2009    Key Record Dates
Last Update Posted: May 3, 2013
Last Verified: May 2013

Keywords provided by Abiomed Inc.:
Patient receiving AB5000 ventricle potentially recoverable