Voyager I: Patient Discharge Using the AB5000 Portable Driver System

This study has been terminated.
(Terminated due to slow enrollment and change in business priority)
Sponsor:
Information provided by (Responsible Party):
Abiomed Inc.
ClinicalTrials.gov Identifier:
NCT00971776
First received: September 2, 2009
Last updated: May 1, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Acute Cardiac Dysfunction
Device: AB Portable Driver System
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Voyager I: Patient Discharge Using the AB5000 Portable Driver System

Further study details as provided by Abiomed Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 9
Study Start Date: June 2008
Estimated Study Completion Date: September 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: AB Portable Driver System
    Evaluate the safety and performance of the AB Portable Driver System in home environment.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Abiomed Inc.
ClinicalTrials.gov Identifier: NCT00971776     History of Changes
Other Study ID Numbers: Voyager I: G80013/S001
Study First Received: September 2, 2009
Last Updated: May 1, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 29, 2014