3 results
Primary Safety Objective : To evaluate one month procedural and device safety of the Tendyne Bioprosthetic Mitral Valve System.Primary Safety Endpoint : Device success and freedom from the following device- or procedure-related serious adverse…
Primary end points:Safety (>1 toxic death per arm) and tolerability (relevant grade 4 toxicities) in not more than 33% of patients for the three treatment arms.Secondary end points:* Reduction of grade 2-4 key side effects in the experimental…
Primary Objective • To assess the effects of 80mg of furosemide delivered by subcutaneous delivery in the abdominal area over 5 hours when compared to oral administration in patients with heart failure with chronic fluid overload. Secondary…