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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of the VentrAssistTM Left Ventricular Assist Device for the Treatment of Advanced Heart Failure - Destination Therapy

Conditions
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Cardiomyopathies, End-stage Heart Failure

Intervention / Treatment
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* Device: VentrAssistTM Left Ventricular Assist Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: VentrAssistTM Left Ventricular Assist Device|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| •Safety •Functional Status and Hospitalizations •Quality of Life and Neurocognitive Assessment |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VentrAssistTM, LVAD, End-stage heart failure, Cardiomyopathy