Primary Investigator:
Timothy Icenogle MD

Description:
Patients who are not candidates for heart transplant owing to age or other diseases and have been treated with all medical management available and are still in danger of dying are implanted with this axial flow pump. The patient is randomized to the study device or the only approved device for DT, the HeartMate XVE LVAD. The device is designed to support their heart for years. The patient will be followed for the rest of his life.

Eligibility:

• Age ≥ 18 years 
• BSA ≥ 1.2 m ²    
• Patient is not a transplant candidate
• Patient has had optimal medical management for 60 out of the last 90 days
• Able to return to the clinical site for all routine follow-up while the LVAD is in. 
• EF less than or equal to 25%
• VO2< 14 or inotropic dependent
• Other eligibility criteria may apply. Please contact study coordinator.

Exclusions:

• Cardiac surgery within 30 days
• Heart Attack within the last two days
• Heart transplant, or LVAD in place at time of surgery
• Un-repairable aortic valve
• Severe bleeding disorders, liver or lung disease
• Dialysis or creatinine greater than 3.5
• Stroke in the last 90 days
• Peripheral vascular disease of the legs that causes you pain or ulcerations
• Unable to take blood thinners
• Other exclusion criteria may apply. Please contact study coordinator

Study Timeline:
Currently enrolling

Study Contact:

Mark, ARNP
puhlmam@shmc.org

Study Sponsor:
Thoratec