4 results
Primary Objective:* Assess the safety and performance of the MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System (BRS) in subjects with de novo native coronary artery lesions as indicated by proportion of population reporting with…
Primary Objective: To obtain real world data on the use of, and provide continued evidence on safety and effectiveness of the FARAPULSE* Pulsed Field Ablation (PFA) system, when used per hospitals* standard of care.Secondary Objective: To understand…
The primary objective of this study is to assess the diagnostic accuracy, in terms of sensitivity and negative predictive value, of preoperative 68Ga-Tilmanocept PET/CT combined with conventional lymphoscintigraphy for SLN detection. Besides, we aim…
The objective of the ADVANTAGE AF Study is to establish the safety and effectiveness of the FARAPULSE Pulsed Field Ablation System (FARAPULSE PFA System) for treatment of drug resistant, symptomatic persistent atrial fibrillation (PersAF).