VentrAssistTM LVAD for the Treatment of Advanced Heart Failure - Destination Therapy

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:

NCT00490321

First received: June 20, 2007

Last updated: September 4, 2009

Last verified: September 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	June 20, 2007
Last Updated Date	September 4, 2009
Start Date ^ICMJE	June 2007
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: October 23, 2007)	Module A: Survival without a disabling stroke. Module B: A composite endpoint of disabling stroke-free survival without device replacement or repair due to failure of the device to provide adequate circulatory support.
Original Primary Outcome Measures ^ICMJE (submitted: June 20, 2007)	Survival
Change History	Complete list of historical versions of study NCT00490321 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 20, 2007)	•Safety •Functional Status and Hospitalizations •Quality of Life and Neurocognitive Assessment
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	VentrAssistTM LVAD for the Treatment of Advanced Heart Failure - Destination Therapy
Official Title ^ICMJE	Evaluation of the VentrAssistTM Left Ventricular Assist Device for the Treatment of Advanced Heart Failure - Destination Therapy
Brief Summary	The purpose of this study is to evaluate the safety and effectiveness of LVADs in providing long-term circulatory support for patients who have chronic stage D heart failure and are ineligible for a heart transplant. This is a multi-center, prospective, randomized, controlled clinical trial, which is comprised of two independent modules.
Detailed Description	Currently, patients with Stage D heart failure who are not transplant candidates are treated with a spectrum of therapies, including specialized medical management as well as mechanical support with an LVAD approved by FDA for destination therapy. However, there is substantial variation in the therapeutic approaches employed to treat these patients, with relatively low numbers of patients receiving DT LVAD therapy to date. Therefore, the VentrAssist DT trial is designed to provide maximal flexibility to the investigators/clinicians to incorporate their clinical judgment in managing these complex patients.
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	End-stage Heart Failure Cardiomyopathies
Intervention ^ICMJE	Device: VentrAssistTM Left Ventricular Assist Device
Study Arm (s)
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	225
Estimated Completion Date	June 2012
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria (The following are general criteria; detailed criteria are included in the study protocol): Eligible for either the VentrAssist or an FDA-approved DT LVAD LVEF <=25% Stage D heart failure Ineligible for cardiac transplantation Treated with standard heart failure therapy Exclusion Criteria (The following are general criteria; detailed criteria are included in the study protocol): Contraindication to LVAD implantation Contraindication to anticoagulant or anti-platelet agents. Pre-existing mechanical circulatory support other than intra-aortic balloon pump Therapy with an investigational intervention at the time of screening A condition, other than heart failure, which would limit survival to less than 2 years
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00490321
Other Study ID Numbers ^ICMJE	CLP 12082
Has Data Monitoring Committee	Yes
Responsible Party
Study Sponsor ^ICMJE	Ventracor
Collaborators ^ICMJE	International Center for Health Outcomes and Innovation Research
Investigators ^ICMJE
Information Provided By	Ventracor
Verification Date	September 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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