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HeartMate® II Study for Advanced-stage Heart Failure Patients—Results and Enrollment Information

HeartMate® II LVAD

NewYork-Presbyterian/Columbia University Medical Center (NYP/CUMC) is participating in the multicenter phase II pivotal clinical trial of the HeartMate® II Left Ventricular Assist System (LVAS) for advanced-stage heart failure patients.

The HeartMate II is a continuous flow device manufactured by Thoratec Corporation. It is designed to provide long-term cardiac support for advanced-stage heart failure patients. An implantable LVAS (Left Ventricular Assist System) powered by a rotary pumping mechanism, it is significantly smaller than currently approved devices. The HeartMate II is designed to have a much longer functional life than other approved devices and to operate more simply and quietly. Patients implanted with the device may return home and resume an active life.

Trial Design

Results of the multicenter phase I trial, released in November, 2005 were positive and led to HeartMate II CE Mark approval for distribution in Europe. The phase II study is anticipated to lead to FDA approval for the device's use in the United States.

The Phase II U.S. pivotal trial is comprised of two study arms: (1) patients who are eligible for cardiac transplantation (Bridge-to-Transplantation/BTT) and (2) patients for whom cardiac transplantation may not be an option (Destination Therapy/DT)).

Results

As of April 27, 2007, more than 700 patients have received a HeartMate II device, including 53 in phase I, 133 in the phase II U.S. BTT trial, 261 in the U.S. DT trial, 164 in the U.S. BTT continuous access protocol, and more than 150 implants in Europe after CE Mark approval.

Data on the first 133 patients enrolled in the U.S. BTT trial reflect patient follow-up through the end of December 2006 for 133 patients enrolled at 26 centers from March 2005 through May 2006:

79 percent of patients were either bridged to transplant, recovered or were ongoing at 180 days
Mean support duration for patients in the trial was 169 days, with one patient supported by the device for 600 days
Patients ranged in age from 18 to 69 years

Collectively, the HeartMate II clinical trial investigations are providing experience with long-term implantation of the device.More than 80 patients in the Phase I and Phase II trial populations have now been supported for more than one year, eight have been supported for over two years and one patient has been supported for over three years.

Continued Enrollment

The clinical trial (including both the BTT continuous access protocol and the DT protocol) is ongoing and still enrolling patients. Criteria are as follows:

Inability to walk one block without shortness of breath
One hospital admission in the past six months
Intolerant or refractory to ACE/ARB/BB
QRS > 140
Sodium < 136
BUN > 40 or Serum Creatinine >1.5
Decline in nutritional condition Albumin < 3.5
Diuretic dose > 1.5 mg/kg/d
Hct < 35
Considering commencement of inotropes

Contact Information

If you or a family member are interested in joining the HeartMate® II LVAS multicenter phase II pivotal clinical trial, please call 212.305.0828 or 305.6003.

Device Guidelines from the Medical Community

Heart failure practice guidelines issued by the Heart Failure Society of America recommend Ventricular Assist Devices (VADs) as a bridge-to-transplantation and for permanent long-term support. The guidelines, released in 2001, noted that VADs should be considered as a bridge-to-transplantation for patients awaiting heart transplantation who have become resistant to all means of medical management and for patients with severe forms of heart failure who are not candidates for transplantation—known as Destination Therapy—particularly those who cannot be weaned from intravenous drug support. The American College of Cardiology and American Heart Association issued similar guidelines regarding the use of VADs in September 2005.