Original articleCardiovascularClinical Evaluation of the CorCap Cardiac Support Device in Patients With Dilated Cardiomyopathy
Section snippets
Overall Study Design
The primary objective of the Acorn trial was to determine the safety and efficacy of the CorCap CSD in patients with heart failure who were receiving optimal medical therapy. Patients who had significant mitral regurgitation and a clinical indication for mitral valve replacement (MVR), as determined by the site clinician, were prospectively enrolled in the MVR stratum (193 patients), and were randomized to either treatment (MVR surgery plus CSD) or control (MVR surgery alone). Patients without
Results
The study enrolled 300 patients at 29 centers. At the common closing date (July 4, 2004) the median duration of follow-up was 22.9 months, with a range of 12 to 48 months. The total patient-years of follow-up were 504 years. Table 1 summarizes baseline demographics. Overall the treatment and control groups were well-balanced; there were, however, small but statistically significant differences with respect to gender and peak oxygen consumption. In addition, diastolic blood pressure was
Comment
The Acorn trial demonstrates that use of a CSD in patients with heart failure leads to salutary changes in LV structure (decreased LV volumes and decreased LV sphericity) and significant improvements in patient functional status and quality of life. The primary endpoint showed that CSD-treated patients had a 73% better odds of having a better clinical outcome relative to patients in the control arm (1.73 [CI: 1.07 to 2.79; p = 0.024]). The individual components of the clinical composite
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Cited by (0)
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On behalf of the Acorn Trial Principal Investigators and Study Coordinators. Participating investigators and study centers are listed in Appendix 1.