3 results
All efficacy study objectives will be assessed in the pediatric AS study population of subjects who are 4 to 12 years old. All safety study objectives will be assessed in the pediatric AS study population of subjects who are 2 to 12 years old.…
The primary objective of this study is to evaluate the long-term safety and tolerability of OV101 in individuals with AS assessed by the incidence and severity of AEs and SAEs in subjects who are at least 2 years old.The secondary objectives of this…
The major objective of this clinical investigation is to demonstrate safety and effectiveness of the ablation system (OMNYPULSE* Bi-Directional Catheter and TRUPULSE* Generator) when used for isolation of the atrial PVs in treatment of subjects with…