3 results
(1) Establishing normal values (cut-offs) for bipolar and unipolar voltage mapping during sinus rhythm and pacing. (2) Establish normal values for conduction velocity during sinus rhythm of the 4 chambers. (3) Establish normal values for activation…
Primary clinical investigation objectives[Safety]The primary safety objective of the clinical investigation is to provide data that demonstrates safety of the device, defined as < 8.3% serious adverse device effects, up to 6 weeks following…
Primary:* To prove the superiority of a 48-weeks treatment with 3.2 g/day delayedreleasephosphatidylcholine (LT-02) versus placebo for the maintenance ofremission in patients with ulcerative colitis (UC)Secondary:* To study safety and tolerability…