Swartz Sheath With Angioplasty Guidewire-Assisted Technique for Patent Foramen Ovale Closure (STAGE-PFO)

Condition(s) studied

Investigational drug(s) / intervention(s)

Swartz sheath with Angioplasty Guidewire-Assisted Technique for PFO tunnel passage: The angioplasty guidewire is advanced into the left atrium and left superior pulmonary vein (LSPV). The Swartz sheath is then delivered to the left atrium along the 0.014" guidewire through the PFO. Next, the Runthrough guidewire is changed to a 0.035" J-tipped guidewire, which is advanced into the LSPV. Finally, the delivery sheath for the PFO closure device is introduced to the left atrium along the guidewire, and all other toolkits are withdrawn.

Conventional technique to pass the PFO tunnel: In the conventional group, the PFO closure procedure is performed with a multi-functional catheter and guided by intraprocedural fluoroscopy and ICE

Study summary

The technical challenge in patent foramen ovale (PFO) closure lies in successfully establishing an occlusion pathway through the PFO tunnel using a guidewire or catheter. In this study, we aim to investigate the efficacy and safety of Swartz sheath with angioplasty guidewire-assisted technique for PFO Closure.

Eligibility

Primary outcome measure(s)

• Time of PFO tunnel passage — Intraprocedural assessment (measured in minutes )
  The total time required to pass the guide across PFO tunnel

Trial sites (1)

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