Evaluation of the Safety and Effectiveness of the DuraHeart™ LVAS

Study Overview
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Brief Summary
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Specific Aims The aims of this trial are to evaluate the safety and effectiveness of the DuraHeart™ LVAS in patients with advanced heart failure who require LVAS support as a bridge to cardiac transplantation. Study Population The patient population for this trial consists of patients with end stage heart failure awaiting cardiac transplantation. Patients must be listed for transplant with UNOS with status 1A or 1B. All patients who meet the eligibility criteria may be included in the study regardless of gender, race or ethnicity. Study Design This is a multi-center, prospective, single arm study in which the lower one-sided confidence interval exceeds the performance goal. Enrollment is expected to occur within an 18-month time period at up to 40 centers. All patients will be followed for all endpoints for 6 months while on DuraHeart™ LVAS support, or until cardiac transplantation or death, whichever occurs first. For those patients who remain on support after 180 days, survival and device reliability data will continue to be collected on a regular basis. If patients are transplanted, survival at day 30 post cardiac transplantation will also be assessed.

Official Title
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Evaluation of the Safety and Effectiveness of the DuraHeart™ Left Ventricular Assist System in Patients Awaiting Transplantation

Conditions
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Heart Failure

Intervention / Treatment
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* Device: DuraHeart Left Ventricular Assist System (LVAS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The following are general criteria; more specific conditions are included in the study protocol: Approved for cardiac transplantation Listed with UNOS on the Status 1 list Patient for whom LVAS implantation is planned as a clinically indicated bridge to cardiac transplantation Exclusion Criteria: The following are general criteria; more specific conditions are included in the study protocol: Contraindication to the administration of warfarin or anti-platelet agents Primary coagulopathy or platelet disorder Acute myocardial infarction within 48 hours prior to enrollment Anticipated need for RVAD support or ECMO at the time of LVAS implantation Prior cardiac transplantation, left ventricular reduction surgery, cardiomyoplasty, passive restraint device (i.e., CorCapTM Cardiac Support Device) or surgically implanted left ventricular assist device

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Historical Data<br>DuraHeart Patients will be implanted with a DuraHeart Left Ventricular Assist System (LVAS) as a bridge to transplant until a suitable heart can be found as a replacement. Parameters collected will be compared to a performance goal based on historical data for congestive heart failure patients | Device: DuraHeart Left Ventricular Assist System (LVAS)<br>* The DuraHeart LVAS is implanted in using open heart surgery<br>* Other names: LVAD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival to cardiac transplantation or to 180 days post implantation and listed for cardiac transplantation in categories UNOS 1A or 1B. |  | 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, LVAS, LVAD, Rotary Pump