Biomedical device company Biotronik of Berlin announced the enrollment of the first European patients in a clinical trial to investigate the efficacy of echocardiography-guided cardiac resynchronization therapy (EchoCRT).
The largest prospective, randomized, double-blind, international, multicenter clinical trial of its kind, the study is designed to investigate whether optimal medical therapy plus CRT will reduce all-cause mortality or first hospitalization for patients with progressive heart failure versus patients who receive only optimal medical therapy without CRT.
Criteria for enrollment in the trial include patients with echocardiographic evidence of left ventricular dyssynchrony with a narrowed width during the QRS segment (< 130 msec) verified on ECG. Worldwide, 125 sites will participate with 80 sites in Europe and Australia. The first of a total of 1,258 patients was enrolled in the trial in the U.S. in August 2008.
Study design is structured with all enrolled patients required to receive current standard pharmacological therapy and be implanted with the Biotronik Lumax HF-T CRT-D device prior to randomization either to the group that receives active CRT or the group who receive pharmacologic therapy alone. Patients then will be followed for a mean duration of 24 months.
Principal investigators, Dr. Johannes Holzmeister and Dr. Frank Ruschitzka are both from the University of Zurich in Switzerland.
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