- Micromed DeBakey VAD bridge to transplant trial. A small axial flow pump is used to bridge patients to transplant who are on the transplant waiting list and have become too sick for transplant. The trial is a multi-institutional pivotal trial.
- Thoratec HeartMate II Bridge to Transplant Trial. Another small axial flow pump is used to bridge patients to transplant who are on the transplant waiting list and have become too sick for transplant. The trial completed the feasibility study phase in which we enrolled the largest number of patients in the country.
We are currently conducting pivotal trials using the same device. The pivotal trials consist of two studies. One is a bridge to transplant therapy and the other a destination therapy. In the multi-institutional bridge to transplant trial, a small axial flow pump, HeartMate II, is used to bridge patients to transplant who are on the transplant waiting list but who have become too sick for transplant.
In the HeartMate II Destination Trial, the device is used to help patients with end-stage heart failure who not eligible for heart transplantation. We are enrolling patients for this multi-institutional, randomized trial.
- Impella Feasibility Trial . The device is a small axial flow pump that can be inserted through the ascending aorta or the femoral or axillary artery. The device is designed to help patients in acute cardiogenic shock, such as large myocardial infarction, severe myocarditis, and post-cardiotomy shock. The trial is now completed and we are in the process of conducting a pivotal trial.
- VentrAssist VAD Bridge to Transplant Trial. A small centrifugal flow pump, a third generaton pump, is used to bridge patients to transplant who are on the transplant waiting list but who have become too sick for transplant. The trial is a multi-institutional feasibility trial.
NewYork-Presbyterian is a leader in the development and implantation of the LVAD (left ventricular assist device), a mechanical pump that augments the function of the left ventricle – the heart’s most critical pumping chamber. These artificial heart devices consist of an electric pump, an electronic control system, and a power supply. The pump is implanted into the upper part of the abdominal wall and is connected to the heart at two points. A tube carries blood from the left ventricle to the pump.
Blood is pumped through a second tube to the aorta, from which it is distributed to all parts of the body, thereby helping a weakened heart circulate blood. A third tube extends to the outside of the body. In this tube are wires that connect the pump to the small controller which can be worn on a belt. The controller is connected to small batteries that are worn on a shoulder holster.
NewYork-Presbyterian offers several types of FDA-approved LVADs for use as a bridge to transplantation, allowing critically ill patients to live productive lives at home while waiting for a heart donor. NewYork-Presbyterian is also participating in ongoing clinical investigations of the next generation of LVADs.
In addition to patients who are waiting for a heart transplant, there are up to 100,000 people who are terminally ill with end-stage heart failure and for whom transplant is not possible. Clinical trials conducted at NewYork-Presbyterian have led to FDA approval of one of these devices — the HeartMate LVAD — for use both as a bridge to transplantation as well as for long-term therapy in the treatment of end-stage heart disease in patients who are not eligible for heart transplantation. Research conducted at NewYork-Presbyterian has demonstrated that patients with the implanted HeartMate LVAD had much better survival rates and quality of life compared patients who were treated with medication and medically monitored. Ongoing and future clinical investigations at NewYork-Presbyterian will examine other LVADs that are much smaller and more durable for long-term use in heart failure patients.
Current LVAD Clinical Investigations