Multicenter InSync ICD Randomized Clinical Evaluation

The Multicenter InSync ICD Randomized Clinical Evaluation (MIRACLE ICD) trial was a randomized, double-blind, parallel-controlled trial of a high-risk population that included patients with left ventricular ejection fraction < 0.35, QRS duration > 130ms and New York Heart Association Functional Class III or IV despite optimal medical beatment. Patients received devices with combined CRT and ICD capabilities and were randomized to the ICD therapy on or off. At 6 months, patients assigned to CRT had a greater improvement in median quality of life score and functional class as compared to controls. No significant differences were observed in changes in left ventricular size or function, overall heart failure status, survival, and rates of hospitalization. No proarrhythmia was observed and arrhythmia termination capabilities were not impaired (82). 

The Multicenter InSync ICD Randomized Clinical Evaluation II (MIRACLE ICD II) was a follow-up randomized, double-blind, parallel-conlrolled clinical trial of CRT in New York Heart Association Functional Class II heart failure patients on optimal medical therapy with a left ventricular ejection fraction < 0.35, a QRS > 130ms and a Class I indication for an ICD. Patients were randomized to control group (ICD activated, CRT off) and to CRT group (ICD activated, cardiac-resynchronization therapy on). No significant differences were noted in 6-min walk distance or quality of life scores or peak V02. There were significant improvements in left ventricular diastolic and systolic volumes and in left ventricular ejection fraction (198). 

Pires, L.A., et al.. Clinical predictors and timing of New York Heart Association class improvement with cardiac resynchronization therapy in patients with advanced chronic heart failure results from the Multicenter InSync Randomized Clinical Evaluation (MIRACLE) and Multicenter InSync ICD Randomized Clinical Evaluation (MIRACLE-ICD) trials. Am Heart J, 2006. 151(4) p. 837-13. 

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