Clinical Trials: VADs, ECMO and The Total Artificial Heart
Next Generation Vads
Columbia is a leading center for clinical trials of devices for bridge to transplant and destination therapy. Our HeartMate® II bridge-to-transplant (BTT) treatment trial has resulted in FDA approval for BTT use of the device. HeartMate® II is now commercially available as destination therapy as well.
We are currently investigating HeartWare® VAD, a new assist device with a magnetically levitated implantable centrifugal blood pump. This is suitable for patients with left ventricular failure who have received and failed optimal medical therapy and who are ineligible for cardiac transplantation. Its small size allows implantation without the creation of a pocket.
Clinical trials for bridge-to-transplant use have shown excellent results so we have beun looking at the potential of the HeartWare® VAD for destination therapy. The ENDURANCE trial is a prospective, randomized, unblinded, multi-center, non-inferiority evaluation of the HeartWare® versus HeartMate® II.
In addition, we are participating in two trials that may alter the management of patients with end-stage heart failure. In fall, 2011 we will start enrolling patients to test the hypothesis that VAD therapy improves both survival and quality of life in advanced heart failure patients who are neither inotrope-dependent nor exercise-intolerant and who have not yet developed serious consequences such as malnourishment, end-organ damage, and immobility. To that end, we will be testing HeartWare® VAD in the REVIVE-IT trial (Randomized Evaluation of VAD InterVEntion before Inotropic Therapy) as well as HeartMate® II in ROADMAP (Risk Assessment and Comparative Effectiveness Of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients) trial.
Our other ongoing studies include The Cohort Study of Patients with Ventricular Assist Device and their Family Caregivers to Assess Symptoms.
The Total Artificial Heart
NewYork-Presbyterian is participating in a multicenter trial for the Freedom Driver, a small mobile controller for patients who have received the Syncardia Total Artificial Heart. In the past, artificial hearts have had such large controllers that patients had to remain in the hospital. With the Freedom driver, however, patients can move around more easily and may be discharged home.
We are also engaged in Syncardia Post Market Surveillance to demonstrate that the results of the pivotal clinical investigation of the Total Artificial Heart are generalizable to new clinical sites.
Short-term Support Devices/ECMO
In addition to the above mentioned trials for chronic heart failure, our program is one of the largest centers to study device therapy for the management of acute heart failure/cardiogenic shock.
We are participating in The CentriMag® Pivotal Trial to evaluate the safety and effectiveness of the Levitronix® CentriMag® VAD for support of patients with cardiac dysfunction and failure-to-wean from cardiopulmonary bypass. This ECMO is a relatively new ventricular assist device, which has a magnetically levitated bearingless pump. In this registry study, we are testing this device in patients who are hemodynamically unstable and who are unable to be moved from the operating room without mechanical circulatory support.
Our use of ECMO for cardiogenic shock led into our participation in the first US feasibility study on CardioHelp ECMO system. This is a very compact and portable ECMO system, allowing transport of these extremely sick patients.