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Study Methods
- Study was not blinded; however members of the end-points committee were not aware of patients’ treatment assignments
- Steering committee designed the trial
- An independent clinical-research organization (Quintiles, Dublin) maintained the database
- Medtronic sponsored the study but had no access to the database and did not participate in data analysis or the writing of articles
- Patients were randomly assigned to treatment group
| Inclusion Factors All patients received standard pharmacologic therapy. Patients were at least 18 years old with heart failure for at least 6 weeks (NYHA class III or IV), with evidence of left ventricular systolic function and cardiac dyssynchrony. |
Exclusion factors Exclusion factors Patients who had a major cardiovascular event in the previous 6-weeks, those who were indicated for a pacemaker or ICD, and those with heart failure requiring continuous intravenous therapy. Patients with atrial arrhythmias. |