Amulet or Watchman Device for Percutaneous Left Atrial Appendage Closure: Primary Results of the SWISS-APERO Randomized Clinical Trial.
Background:No study has so far compared Amulet with the new Watchman FLX in terms of residual left atrial appendage (LAA) patency or clinical outcomes in patients undergoing percutaneous LAA closure.Methods:In the investigator-initiated SWISS APERO trial (Comparison of Amulet Versus Watchman/FLX Device in Patients Undergoing Left Atrial Appendage Closure), patients undergoing LAA closure were randomly assigned (1:1) open label to receive Amulet or Watchman 2.5 or FLX (Watchman) across 8 European centers. The primary end point was the composite of justified crossover to a nonrandomized device during LAA closure procedure or residual LAA patency detected by cardiac computed tomography angiogr…
TCT-350 Safety and Performance of the Resorbable Magnesium Scaffold, Magmaris in a Real World Setting - First 400 Subjects at 12-month Follow-up of the BIOSOLVE-IV Registry
The aim of this registry is to investigate the clinical performance and long-term safety of the Resorbable Magnesium Scaffold (Magmaris) (BIOTRONIK AG, Buelach, Switzerland) in a real-world setting. Up to 2,054 subjects in up to 120 clinical sites in Europe, Asia, and Asia-Pacific countries will