3 results
Primary Safety Endpoint:Safety will be assessed by incidence and severity of adverse events through 12-weeks (3 month) follow-up. Included in this assessment will be the proportion of subjects with any of the following outcomes between device…
The primary objective is to evaluate the safety and efficacy of the PulseCath during support of patients with impaired ventricular function, for a period between 24 hours minimum and 14 days maximum. Safety will be assessed by the incidence of…
Primary Objective: Therapeutic effect of electrical stimulation. Secondary Objective(s): (i) Side effects of electrical stimulation(ii) Effect on quality of life (iii) Effect of electrical stimulation on inflammatory and histologic parameters.