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

NARecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

December 24, 2023

Primary Completion Date

March 30, 2025

Study Completion Date

May 30, 2025

Conditions
Patent Oval Foramen
Interventions
PROCEDURE

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sheath for the PFO closure device is introduced to the left atrium along the guidewire, and all other toolkits are withdrawn."

PROCEDURE

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

Trial Locations (1)

200127

RECRUITING

Renji Hospital, Shanghai

All Listed Sponsors
lead

RenJi Hospital

OTHER