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Clinical Trials
In late 2008 HeartWare completed enrollment of a 50-patient international clinical trial for the HeartWare Ventricular Assist System. The company received CE Mark approval in January 2009 based on data submitted for the first 25 patients. The HeartWare System is commercially available in the European Union.
The purpose of the international trial was to evaluate the safety and feasibility of the System as a bridge to cardiac transplantation in patients eligible for cardiac transplantation with refractory, end-stage heart failure at risk of death. The primary endpoint was survival to anesthetic induction for heart transplantation or survival to 180 days on the device and listed for transplantation.
The study was a multi-centre, prospective, non-randomized, single-arm study, enrolling patients across five participating centers. HeartWare completed enrollment of the initial 20 patients in late 2007 and applied subsequently to extend enrollment to 50 patients.
The five participating centers with their respective principal investigators were as follows:
| Vienna General Hospital, Austria |
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Dr George Wieselthaler |
| Royal Perth Hospital, Australia |
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Dr Gerry O'Driscoll |
| Hannover Medical Center, Germany |
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Dr Martin Struber |
| Harefield Hospital, UK |
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Dr Asghar Khaghani |
| St Vincent's Hospital, Australia |
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Dr Paul Jansz |
Clinical results from the first 23 patients enrolled in the international trial were presented by Dr Georg Wieslethaler at the ISHLT Meeting in Boston in April 2008. Of these first 23 patients, 21 patients (or 91%) successfully met the primary endpoint of the trial, namely survival to 180 days or transplantation.
US Clinical Trials
In the United States, the HeartWare(R) Ventricular Assist System is the subject of an ongoing bridge-to-transplant clinical trial under which HeartWare enrolled 140 patients at 30 participating centers. Patient follow-up for that study is expected to conclude in August 2010, with subsequent PMA submission to the FDA. In April 2010, the U.S. Food and Drug Administration (FDA) approved an IDE (Investigational Device Exemption) Supplement that allows HeartWare to enroll up to an additional 54 patients in its bridge-to-transplant clinical trial under a Continued Access Protocol (CAP).
In June 2010, the FDA granted HeartWare conditional approval to begin enrollment in an IDE destination therapy clinical study for the HeartWare(R) Ventricular Assist System. Designed to enroll 450 patients at 50 U.S. hospitals, the non-inferiority study, which is named "ENDURANCE," is a randomized, controlled, unblinded, multi-center clinical trial to evaluate the use of the HeartWare Ventricular Assist System as a destination therapy in advanced heart failure patients. The study population will be selected from patients with end stage heart failure who have not responded to standard medical management and who are ineligible for cardiac transplantation.
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