Heart Failure
Conditions
Keywords
Heart Failure, LVAS, LVAD, Rotary Pump
Brief summary
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.
Interventions
DEVICEDuraHeart Left Ventricular Assist System (LVAS)
The DuraHeart LVAS is implanted in using open heart surgery
Sponsors
Terumo Heart Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The following are general criteria; more specific conditions are included in the study protocol: 1. Approved for cardiac transplantation 2. Listed with UNOS on the Status 1 list 3. 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: 1. Contraindication to the administration of warfarin or anti-platelet agents 2. Primary coagulopathy or platelet disorder 3. Acute myocardial infarction within 48 hours prior to enrollment 4. Anticipated need for RVAD support or ECMO at the time of LVAS implantation 5. Prior cardiac transplantation, left ventricular reduction surgery, cardiomyoplasty, passive restraint device (i.e., CorCapTM Cardiac Support Device) or surgically implanted left ventricular assist device
Design outcomes
Primary
| Measure | 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 |
Countries
Canada, United States
Outcome results
None listed