VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Pivotal Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Ventracor.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
International Center for Health Outcomes and Innovation Research
Information provided by:
Ventracor
ClinicalTrials.gov Identifier:
NCT00483197
First received: June 4, 2007
Last updated: September 4, 2009
Last verified: September 2009
  Purpose

The purpose of this study is to evaluate the safety and effectiveness of VentrAssistTM LVAD in individuals who are awaiting heart transplants.


Condition Intervention Phase
End-stage Heart Failure
Cardiomyopathies
Device: VentrAssistTM Left Ventricular Assist Device
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: Treatment
Official Title: Evaluation of the VentrAssistTM Left Ventricular Assist Device as a Bridge to Cardiac Transplantation - Pivotal Trial

Resource links provided by NLM:


Further study details as provided by Ventracor:

Primary Outcome Measures:
  • Survival to cardiac transplantation or to 180 days post implantation and listed for cardiac transplantation in categories UNOS 1A or 1B.

Secondary Outcome Measures:
  • Quality of life
  • Functional status
  • Neurocognitive function

Estimated Enrollment: 140
Study Start Date: June 2007
Estimated Study Completion Date: June 2010
Detailed Description:

LVADs are efficacious in improving survival and functional status when used as a bridge to transplantation. The purpose of this study is to evaluate the safety and effectiveness of the VentrAssist LVAD in providing circulatory support in individuals who are awaiting heart transplants.

The VentrAssist LVAD is a centrifugal flow pump. Its small size and mechanical simplicity offers benefits not available with currently approved LVADs, including facilitating a more limited implantation procedure, which could reduce surgical morbidity and mortality.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483197

  Show 29 Study Locations
Sponsors and Collaborators
Ventracor
International Center for Health Outcomes and Innovation Research
  More Information

No publications provided

Responsible Party: Nader Moazami, MD Sugical PI, Washington Hospital/Barnes Jewish Hospital
ClinicalTrials.gov Identifier: NCT00483197     History of Changes
Other Study ID Numbers: CLP 06005
Study First Received: June 4, 2007
Last Updated: September 4, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Ventracor:
VentrAssistTM
LVAD
End-stage heart failure
Cardiomyopathy

Additional relevant MeSH terms:
Heart Failure
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 28, 2014