A prospective, multi-center randomized trial comparing the Revivent System plus GDMT to GDMT alone. A total of approximately 135 subjects will be randomized in a 2:1 allocation ratio (90 treatment and 45 control), with approximately 128 evaluable patients and assuming 5% loss to follow-up. A primary safety endpoint will be evaluated at 30 days. Primary efficacy endpoint will be at 1 year. Interim efficacy endpoints will be evaluated at 6 months.
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Major Adverse Events Composite Performance Goal
Timeframe: 30 days
Composite Effectiveness Endpoint
Timeframe: 6 Months
Composite Effectiveness Endpoint
Timeframe: 12 Months