An interventional study of Swartz sheath with Angioplasty Guidewire-Assisted Technique for PFO tunnel passage and Conventional technique to pass the PFO tunnel in Patent Oval Foramen, sponsored by RenJi Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-01-27.
Sponsored by RenJi Hospital · Not applicable, Interventional, and Treatment
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.
In cases of complex PFO, failure of guidewire passage through the septum can occur, rendering closure impossible. The present multicenter, prospective, randomized controlled trial aims to evaluate the efficacy and safety of a novel Swartz sheath with angioplasty guidewire-assisted technique to facilitate PFO tunnel passage.
With written consent, the investigators expect to enrol PFO patients with a history of cryptogenic stroke (CS) or transient ischemic attack (TIA), who requires PFO closure according to current guidelines. A standardized TEE protocol is used to assess the morphologic characteristics of the atrial septum and right-to-left shunting through PFO. Eligible patients are prospectively and randomly assigned to the Swartz sheath + angioplasty guidewire group or the conventional group (1:1 ratio). In the Swartz sheath + angioplasty guidewire group, the PFO closure procedure is performed with Swartz sheath + angioplasty guidewire assistance. In the conventional group, the PFO closure procedure is performed with a multi-functional catheter. After the procedure, safety parameters such as contrast use, procedure time, and severe complications are recorded. All patients are followed up at 1-, 3-, 6-, and 12- month post device implantation. The presence of a residual shunt, device embolization, device migration and residual shunt are recorded.
134 studies on the registry are indexed under Foramen Ovale, Patent; 46 are open to participants now.
This study's planned enrollment of 120 is below the median of 152 across 68 interventional studies indexed under Foramen Ovale, Patent.
Browse Foramen Ovale, Patent studies →RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.
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Exclusion Criteria:
In the conventional group, the PFO closure procedure is performed with a multi-functional catheter and guided by intraprocedural fluoroscopy and intracardiac echocardiography (ICE).
Procedure: Conventional technique to pass the PFO tunnel
In the Swartz sheath + angioplasty guidewire group, the PFO closure procedure is performed with Swartz sheath + angioplasty guidewire assistance and guided by intraprocedural fluoroscopy and ICE.
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.
In the conventional group, the PFO closure procedure is performed with a multi-functional catheter and guided by intraprocedural fluoroscopy and ICE
Time of PFO tunnel passage
The total time required to pass the guide across PFO tunnel
Time frame: Intraprocedural assessment (measured in minutes )
Procedure Time
The total time required to complete PFO closcure
Time frame: Intraprocedural assessment (measured in minutes )
Fluoroscopy Time
The total fluoroscopy time during the procedure
Time frame: Intraprocedural assessment (measured in minutes )
Procedural Complications
Complications such as inguinal haematoma and pericardial effusion related to the PFO closure procedure
Time frame: Intraprocedural assessment
Radiation Dose
The total dosage of radiation required to complete the PFO closure procedure
Time frame: Intraprocedural assessment (measured in mGys)
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